Keytruda (pembrolizumab)
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Keytruda (pembrolizumab) is a medication used for the treatment of advanced melanoma, metastatic nonsquamous NSCLC, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), recurrent classical Hodgkin Lymphoma (cHL), locally advanced or metastatic urothelial carcinoma, solid tumours having the biomarkers MSI-H or dMMR, recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, renal cell carcinoma, triple-negative breast cancer.
Note: Keytruda (pembrolizumab) is currently only available in 100mg form (100mg/4ml). There used to be a 50mg presentation but this has been discontinued as of March 15th, 2019.
Disease Indications
Urothelial Carcinoma, Breast Cancer, Colorectal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Lung Cancer, Lymphoma, Skin Cancer
Manufacturer
Merck Sharp
Usage
Intravenous
Medicine approved by
-
European Medical Agency (EMA)
-
Food and Drug Administration (FDA)
-
Health Canada
-
Therapeutic Goods Administration (TGA)
-
Medsafe (NZ)
Patients helped
- Over 2 million patients reached
- More than 11,000 patients helped
- 100% successful deliveries to 88 countries
We can help with your import documents
We are experts in import regulations. Scroll below to download the import guide for your country.
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We help you access approved medicines that are not approved or available in your country of residence.
Legal
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Price
Reimbursement
- That you want to import an approved medicine from abroad
- The lack of reasonable treatment options available in your country (if you can, include a letter from a doctor confirming this) - no alternative to the treatment.
- That the medicine has already been approved in another country (state the name of the country)
- That your treating doctor states that this medicine is the best option for you (include a copy of the prescription in the letter to the healthcare insurance company)
Ordering and shipping
Ordering
- Name of the patient
- Contact details of patient(email and phone number)
- Copy of patient’s ID
- Contact details of the Doctor (name, address, email and phone number)
- Shipping address
- Copy of the doctor's prescription
Shipping: We can deliver to the patient's residence, a pharmacy, or doctor's office / hospital, but this depends on the country. If you’re not sure what the right choice is for you, please get in touch with our Patient Support Team and we can help you work out your exact requirements.
Once we have received this information, one of our Patient Support Team members will then check your prescription and contact you to follow up on your order. Please note that other documents may be needed for import, we will guide you through the ordering process.
Generally not, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details.
As part of our protocols we might reach out to your treating doctor for verification or information updates. By sending us your prescription you allow us to do so.
- Patient's name and date of birth
- Name of the medicine and dosage
- Required quantity
- Doctor's name and signature
- Doctor's registration number and/or stamp
Ideally, the prescription should be issued in English. Alternatively, a translation (unofficial is sufficient) must be provided.
Please be aware that your doctor may be contacted by one of our team members or by the processing pharmacy in order to verify the prescription.
Shipping
Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping.
For EMA approved medicines with prescriptions from within the Schengen zone, you can pick the medicines up from our partner pharmacy in Amsterdam, Luxembourg or Dusseldorf. For non-EMA approved medicines, with prescriptions from within the Schengen zone, you can pick the medicines up in our partner pharmacy in Dusseldorf. If you have requested to collect your medicines, you will receive a notification when the medicines are in the pharmacy and ready for you.
There are also options to deliver the medicines to other countries. Please get in touch with our Patient Support Team to discuss which other pick-up and delivery options may be suitable for you.
- Copy of the ID/passport of the patient
- Copy of the ID/passport of the person who is coming to pick up the medicines
- Letter signed by the patient stating that he/she authorises this person to pick up the medicines on his/her behalf
- Step 1 - Customs may need to check the package to verify its contents. In order to streamline this step, we include a letter for customs with information about the contents. Any additional questions will be answered by TheSocialMedwork as and when we are contacted by customs.
- Step 2 - In some countries, there are additional questions from the medical regulatory agencies (i.e. the FDA, EMA, etc). We provide them with all the necessary information based on the information provided by the patient, such as: the prescription, copy of ID and a letter from the treating doctor to show that the medicines are for personal use.
- Step 3 - Customs fees. In some cases, the recipient will be requested to pay taxes and duties. These should be arranged by the patient or receiver and are not covered by TheSocialMedwork unless stated otherwise.
Please be aware that the import of the medicines always requires customs clearance and active cooperation from the importing party. We will help and guide you but are dependent on your cooperation and responsiveness.
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Others
Available medicines
Medicine approval
The respective national and regional agencies, such as the Food and Drugs Administration (FDA) in the USA or the European Medical Authority (EMA) for the European Union assess these applications and make a decision on whether to approve new medicines. The review process is based on evaluation of the evidence provided by the company. Every agency uses a slightly different process.
- Phase I - performed in a small number of healthy volunteers or very sick patients with lack of treatment options, designed to study the effects of the medicine in the human body.
- Phase II - larger number of patients, designed to evaluate the safety and efficacy of the medicine and to determine if different dosages of the treatment have different effects.
- Phase III - large number of patient groups, designed to confirm the safety and efficacy of the medicine.
- Phase IV - after the medicine has received regulatory approval, designed to evaluate the long-term effects.
Updates
Keytruda (pembrolizumab)
Package
1 vial of powder for infusion
Where can we deliver?
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Our Patient Support Team will personally assist you along the way
Dr. Akshi Sudan
Patient Support Team Lead
Daniela Figueira, PharmaD
Patient Support Agent
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What is Keytruda (pembrolizumab) for?
Keytruda (pembrolizumab) is a monoclonal antibody (immunotherapy) indicated for the treatment of people with:
- advanced (unresectable or metastatic) melanoma1,2,3
- metastatic nonsquamous NSCLC as first-line treatment in combination with pemetrexed and carboplatin1,2,3
- recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)2,3
- recurrent classical Hodgkin Lymphoma (cHL)1,2,3
- locally advanced or metastatic urothelial carcinoma1,2,17
- solid tumours having the biomarkers MSI-H or dMMR1,16
- recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma2,18
- advanced renal cell carcinoma (RCC).
- locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1.
It is available as a powder for intravenous infusion (drip) containing 100mg of pembrolizumab per vial.
Note: Keytruda (pembrolizumab) is currently only available in 100mg form (100mg/4ml). There used to be a 50mg presentation but this has been discontinued as of March 15th, 2019.
How does Keytruda (pembrolizumab) work?
Keytruda (pembrolizumab) is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Keytruda (pembrolizumab) has been designed to attach to and block a receptor called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells, thereby increasing the ability of the immune system to kill cancer cells1.
Where has Keytruda (pembrolizumab) been approved?
Keytruda (pembrolizumab) was approved as an onocology medicine by:
- Food and Drug Administration (FDA), USA:
- September 4, 2014, for advanced or unresectable melanoma2
- October 2, 2015, for advanced (metastatic) NSCLC which progressed after other treatments and with tumours that express a protein called PD-L14
- August 8, 2016, for recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HBSCC)7
- October 24, 2016, as first-line treatment for metastatic NSCLC with PD-L1 expression on ≥ 50 % of cells as determined by an FDA-approved test; in absence of EGFR or ALK genomic tumour aberrations, and for patients with metastatic NSCLC whose tumours express PD-L1 on ≥ 1 % of cells with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on other therapies approved for these aberrations prior to receiving pembrolizumab2,6
- March 14, 2017, for adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy13
- May 10, 2017, in combination with pemetrexed and carboplatin, as first-line treatment for metastatic nonsquamous NSCLC13
- May 18, 2017, for locally advanced or metastatic urothelial carcinoma in patients who are not eligible to (first-line treatment) or have disease progression during or following (second-line treatment) certain chemotherapies2
- May 23, 2017, for adult and pediatric patients with unresectable or metastatic solid tumors having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The indication is for tumours that progressed following prior treatment and who have no satisfactory alternative treatment options16
- September 22, 2017, for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (PD-L1 Combined Positive Score (CPS) ≥1), with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy2.
- November 13, 2020, in combination with chemotherapy for patients with TNBC.
- European Medical Agency (EMA), European Union:
- July 17, 2015, for advanced or unresectable melanoma1
- June 23, 2016, for locally advanced or metastatic NSCLC12
- January 31, 2017, as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation8,9
- May 2017, for relapsed or refractory classical Hodgkin lymphoma (cHL)
- July 20, 2017, for locally advanced or metastatic urothelial carcinoma17
- Therapeutic Goods Administration (TGA), Australia:
- April 16, 2015, for advanced melanoma3
- March 6, 2017, for as first-line treatment of patients with metastatic NSCLC with PD-L1 on ≥50% of cells and without EGFR or ALK mutation12
- March 7, 2017, for advanced non-small cell lung carcinoma (NSCLC)12
- March 21, 2017, for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)3
- for relapsed or refractory classical Hodgkin Lymphoma (cHL)3
- for locally advanced or metastatic urothelial carcinoma3
- Health Canada, January 15, 201919:
- Unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy
- Unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor
- Metastatic non-small cell lung carcinoma (NSCLC) as monotherapy, in adults whose tumours have high PD-L1 expression (TPS ≥50%) as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC
- Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinumcontaining chemotherapy
- Medsafe, New Zealand20:
- for unresectable or metastatic melanoma in adults and the adjuvant treatment of patients with melanoma with lymph node involvement who have undergone complete resection
- for locally advanced or metastatic NSCLC
- relapsed or refractory classical Hodgkin lymphoma (cHL)
- for locally advanced or metastatic urothelial carcinoma
- for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy
- in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
- in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours that have progressed following prior treatment and when there are no satisfactory alternative treatment options
- in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
Please note that this medication may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team for assistance.
Please be aware that any decision to use a prescription brand-name or (cheap) generic medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to wholesale distributors in India concerning the quality of their medicines.
How is Keytruda (pembrolizumab) taken?
The standard dosage is1,2,3:
- Melanoma: 200 mg every 3 weeks
- NSCLC: 200 mg every 3 weeks
- HNSCC: 200 mg every 3 weeks
- cHL: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200mg) every 3 weeks for pediatrics
- Urothelial Carcinoma: 200 mg every 3 weeks
- MSI-H Cancer: 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children
- Gastric Cancer: 200 mg every 3 weeks.
Administer as an intravenous infusion over 30 minutes.
For children with cHL and MSI-H, how much Keytruda (pembrolizumab) is needed depends on the body weight.
Complete information about Keytruda (pembrolizumab) dose and administration can be found in the official prescribing information listed in our references section1,2,3.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Keytruda (pembrolizumab)?
Common side effects
The most common adverse reactions ( ≥20% of patients) listed in the prescribing information include1,2,3:
- fatigue
- musculoskeletal pain
- decreased appetite
- pruritus
- diarrhea
- nausea
- rash
- pyrexia
- cough
- dyspnea
- constipation.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include1,2,3:
- immune-mediated pneumonitis
- immune-mediated colitis
- immune-mediated hepatitis
- immune-mediated endocrinopathies:
- Hypophysitis
- Thyroid disorders
- Type 1 diabetes mellitus
- immune-mediated nephritis
- immune-mediated skin adverse reactions including, StevensJohnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
- Other immune-mediated adverse reactions: In organ transplant recipients
- Infusion-related reactions
- Complications of allogeneic HSCT.
Use in a specific population
Keytruda (pembrolizumab) can be fatal for a fetus; it is not advised for women who are pregnant or breast feeding1,2,3.
Avoid use in patients with a severely damaged immune system1,2,3.
For a comprehensive list of side effects and adverse reactions please refer to the supplier's official prescribing information1,2,3.
References
1. Summary of Product Characteristics (SmPC) [EMA]: Keytruda (pembrolizumab) [PDF]
Merck, May 2017.
2. Summary of Product Characteristics [FDA]: Keytruda (pembrolizumab) [PDF]
Merck, Nov 2017.
3. Summary of Product Characteristics [TGA]: Keytruda (pembrolizumab) [PDF]
Merck, EMA, Jan 2018.
4. FDA News Release: FDA approves Keytruda for advanced non-small cell lung cancer
Oct 2015
5. EMA. Human Medicines: Keytruda (pembrolizumab)
cited March 2017
6. FDA: Approved Drugs. Pembrolizumab (Keytruda) Checkpoint Inhibitor
Oct 2016
7. FDA: Approved Drugs. Pembrolizumab (Keytruda)
Aug 2016
8. EMA. Pending EC Decisions: Keytruda
Dec 2016
9. Inman, S. EC Approves Frontline Pembrolizumab for PD-L1+ Metastatic NSCLC
OncLive, Jan 2017
10. Drugs.com. FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL)
March 2017
11. EMA. Extension of indication variation assessment report
June 2016
12. TGA. Prescription medicines: new or extended uses, or new combinations of registered medicines
May 2017.
13. EMA. Assessment report
March 2017
14. FDA. Approved drugs. Pembrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma
May 2017
16. FDA News Release: FDA approves first cancer treatment for any solid tumor with a specific genetic feature
May 2017
17. EMA. Pending EC decisions. Keytruda
July 2017
18. OncLive. FDA approves pembrolizumab for PD-L1+ gastric cancer
Sept 2017
19. Product Monograph [Health Canada]: Keytruda (pembrolizumab) [PDF]
Merck Canada, Mar 2020.
20. Product Details [Medsafe]: Keytruda (pembrolizumab) [PDF]
Merck, Mar 2020.
Melanoma
The approvals from the the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, for Keytruda (pembrolizumab) for unresectable or metastatic melanoma in previously treated patients were based on several studies (KEYNOTE-0061,2,3, KEYNOTE-0021,2, KEYNOTE-0011,2,3). Patients were treated until disease progression or toxicity.
-
KEYNOTE-006 was a multicentre, controlled, Phase III study and involved a total of 834 patients naïve to ipilimumab and who received no or one prior systemic therapy. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda as an intravenous injection (drip) at a dose of 10 mg/kg every 2 or 3 weeks or ipilimumab, another immunotherapy. Subgroups of patients were identified and compared according to their PD-L1 expression (positive or negative).
-
KEYNOTE-002 was a multicentre controlled study and involved a total of 540 patients previously treated with ipilimumab and if BRAF V600 mutation-positive, a BRAF or MEK inhibitor. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda at a dose of 2 or 10 mg/kg every 3 weeks or chemotherapy (including dacarbazine, temozolamide, carboplatin, paclitaxel, or carboplatin+paclitaxel). Subgroups of patients were identified and compared according to their PD-L1 expression (positive or negative).
-
KEYNOTE-001 open-label study and involved 276 patients who had either been previously treated with ipilimumab (and if BRAF V600 mutation-positive, a BRAF or MEK inhibitor) or who were naïve to treatment with ipilimumab. Patients were randomly assigned to one of 3 groups of similar size and received Keytruda at a dose of 2 or 10 mg/kg every 3 weeks.
Results
The major efficacy outcome measures were progression free survival (PFS), overall survival (OS), overall response rate (ORR), duration of response (DOR).
The median PFS was:
-
in KEYNOTE-0061:
-
4.1 months [95% CI: 2.9, 7.2] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
5.6 months [95% CI: 3.4, 8.2] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks
-
2.8 months [95% CI: 2.8, 2.9] with Ipilimumab 3 mg/kg every 3 weeks
-
in KEYNOTE-0021:
-
2.9 months [95% CI: 2.8, 3.8] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks
-
3 months [95% CI: 2.8, 5.2] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
2.8 months [95% CI: 2.6, 2.6] with chemotherapy
The median OS was:
-
in KEYNOTE-006:
-
Not reached [95% CI: 24 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
Not reached [95% CI: 22 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks
-
16 months [95% CI: 14, 22] with Ipilimumab 3 mg/kg every 3 weeks
-
in KEYNOTE-002:
-
13.4 months [95% CI: 11.0, 16.4] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks
-
14.7 months [95% CI: 11.3, 19.5] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
11.0 months [95% CI: 8.9, 13.8] with chemotherapy
The ORR was:
-
in KEYNOTE-006:
-
36% [95% CI: 30, 42] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
13% complete responses
-
37% [95% CI: 31, 43] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks
-
12% complete responses
-
13% [95% CI: 10, 18] with Ipilimumab 3 mg/kg every 3 weeks
-
5% complete responses
-
PD L1 positive/negative subgroup:
-
40% in PD-L1 positive with Keytruda (pembrolizumab) 10 mg/kg every 2 or 3 weeks vs. 14% with ipilimumab
-
24% in PD-L1 negative with Keytruda (pembrolizumab) 10 mg/kg every 2 or 3 weeks vs. 13% with ipilimumab
-
in KEYNOTE-002:
-
22% [95% CI: 16, 29] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks
-
3% complete responses
-
28% [95% CI: 21, 35] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
7% complete responses
-
5% [95% CI: 2, 9] with chemotherapy
-
0% complete responses
-
PD L1 positive/negative subgroup:
-
25% in PD-L1 positive with Keytruda (pembrolizumab) 2 mg/kg every 2 or 3 weeks vs. 4% with ipilimumab
-
10% in PD-L1 negative with Keytruda (pembrolizumab) 2 mg/kg every 2 or 3 weeks vs. 8% with ipilimumab
The DOR was:
-
in KEYNOTE-0061:
-
Not reached [95% CI: 24 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
Not reached [95% CI: 22 months, NA] with Keytruda (pembrolizumab) 10 mg/kg every 2 weeks
-
16 months [95% CI: 14, 22] with Ipilimumab 3 mg/kg every 3 weeks
-
in KEYNOTE-0021:
-
22.8 months [range: 1.4+, 25.3+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks
-
Not reached [range: 1.1+, 28.3+] with Keytruda (pembrolizumab) 10 mg/kg every 3 weeks
-
6.8 months [range: 2.8, 11.3] with chemotherapy
-
in KEYNOTE-0011:
-
30.5 months [range: 2.8+, 30.6+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks in patients previously treated with ipilimumab
-
27.4 months [range: 1.6+, 31.8+] with Keytruda (pembrolizumab) 2 mg/kg every 3 weeks in patients naïve to treatment with ipilimumab
Non-small cell lung cancer
1st line approval
The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for previously untreated metastatic NSCLC were based on one study (KEYNOTE-0241,2,3). This study involved a total of 305 patients whose tumours had a PD-L1 expression of at least 50%; the study excluded patients with EGFR or ALK mutations. Patients were randomly assigned to one of 2 groups of similar size and received either pembrolizumab at a dose of 200 mg every 3 weeks or investigator’s choice platinum-containing chemotherapy (including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin. Non-squamous patients could receive pemetrexed maintenance). Patients were treated with pembrolizumab until unacceptable toxicity or disease progression up to a maximum of 24 months1.
Results
The major efficacy outcome measures were progression free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DOR).
The median PFS was1,2,3:
-
10.3 months [95% CI: 6.7, N.A.] with Keytruda (pembrolizumab) 200 mg every 3 weeks
-
6.0 months [95% CI: 4.2, 6.2] with chemotherapy
The median OS was1,2,3:
-
Not reached
The ORR was1,2,3:
-
45% [95% CI: 37, 53] with Keytruda (pembrolizumab) 200 mg every 3 weeks
-
4% complete responses
-
28% [95% CI: 21, 36] with chemotherapy
-
1% complete responses
The median DOR was1,2,3:
-
Not reached [range: 1.9+, 14.5+] with Keytruda (pembrolizumab) 200 mg every 3 weeks
-
6.3 months [range: 2.1+, 12.6+] with chemotherapy
2nd line approval
The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for patients previously treated with platinum-containing chemotherapy were based on one study (KEYNOTE-0101,2,3). This study involved a total of 1033 patients whose tumours had a PD-L1 expression of at least 1%; the study included patients with EGFR or ALK mutations who progressed on medicines specific for these indications. Patients were randomly assigned to one of 3 groups of similar size and received either pembrolizumab at a dose of 2 mg/kg every 3 weeks, pembrolizumab at a dose of 10 mg/kg every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression1.
Results
The major efficacy outcome measures were progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DOR).
The median PFS was1,2,3:
-
PD-L1 expression above 1%
-
3.9 months [95% CI: 3.1, 4.1] with Pembrolizumab 2 mg/kg every 3 weeks
-
4.0 months [95% CI: 2.6, 4.3] with Pembrolizumab 10 mg/kg every 3 weeks
-
4.0 months [95% CI: 3.1, 4.2] with docetaxel 75 mg/m2 every 3 weeks
-
PD-L1 expression above 50%
-
5.2 months [95% CI: 4.0, 6.5] with Pembrolizumab 2 mg/kg every 3 weeks
-
5.2 months [95% CI: 4.1, 8.1] with Pembrolizumab 10 mg/kg every 3 weeks
-
4.1 months [95% CI: 3.6, 4.3] with docetaxel 75 mg/m2 every 3 weeks
The median OS was1,2,3:
-
PD-L1 expression above 1%
-
10.4 months [95% CI: 9.4, 11.9] with Pembrolizumab 2 mg/kg every 3 weeks
-
12.7 months [95% CI: 10.0, 17.3] with Pembrolizumab 10 mg/kg every 3 weeks
-
8.5 months [95% CI: 7.5, 9.8] with docetaxel 75 mg/m2 every 3 weeks
-
PD-L1 expression above 50%
-
14.9 months [95% CI: 10.4, NA] with Pembrolizumab 2 mg/kg every 3 weeks
-
17.3 months [95% CI: 11.8, NA] with Pembrolizumab 10 mg/kg every 3 weeks
-
8.2 months [95% CI: 6.4, 10.7] with docetaxel 75 mg/m2 every 3 weeks
The ORR was1,2,3:
-
PD-L1 expression above 1%
-
18% [95% CI: 14, 23] with Pembrolizumab 2 mg/kg every 3 weeks
-
18% [95% CI: 15, 23] with Pembrolizumab 10 mg/kg every 3 weeks
-
9% [95% CI: 7, 13] with docetaxel 75 mg/m2 every 3 weeks
-
PD-L1 expression above 50%
-
30% [95% CI: 23, 29] with Pembrolizumab 2 mg/kg every 3 weeks
-
29% [95% CI: 22, 37] with Pembrolizumab 10 mg/kg every 3 weeks
-
8% [95% CI: 4, 13] with docetaxel 75 mg/m2 every 3 weeks
Head and neck cancer
The approvals from the The Food and Drug Administration (FDA), USA, and Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for recurrent or metastatic head and neck cancer (Head and Neck Squamous Cell Cancer - HNSCC) were based on one study (KEYNOTE-0122,3).
This study involved a total of 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy2. Patients were divided in two groups and received Keytruda 10 mg/kg every 2 weeks (53 patients) or 200 mg every 3 weeks (121 patients) until unacceptable toxicity or disease progression under certain conditions. Patients without disease progression were treated for up to 24 months2.
Results
Among the efficacy outcome measures were the overall response rate (ORR), and duration of response (DOR). These were similar irrespective of dosage regimen (10 mg/kg every 2 weeks or 200 mg every 3 weeks).
The ORR was1,2,3:
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16% (95% CI: 11, 22)
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complete response rate: 5%
The DOR among the 28 responding patients was1,2,3:
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range: 2.4+ to 27.7+ months
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23 patients having responses of 6 months or longer
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The median was not reached
Classical Hodgkin Lymphoma
The approvals from the Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, of Keytruda (pembrolizumab) for relapsed or refractory classical Hodgkin lymphoma (cHL) were based on two multicentre, open-label studies (KEYNOTE-087 and KEYNOTE-0131,2,3). These studies involved a total of 241 patients with cHL. Both studies included patients regardless of PD-L1 expression.
Results
Among the efficacy outcome measures were the overall response rate (ORR), duration of response (DOR), time to response, progression-free survival (PFS) and overall survival (OS).
The ORR was1,2,3:
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69% (95% CI: 62.3, 75.2) in KEYNOTE-087
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Complete remission: 22%
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58% (95% CI: 39.1, 75.5) in KEYNOTE-013
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Complete remission: 19%
The median DOR was1,2,3:
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11.1 months (range: 0.0+, 11.1) in KEYNOTE-087
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% of patients with duration above 6 months: 76%
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Not reached (range: 0.0+, 26.1+) in KEYNOTE-013
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% of patients with duration above 6 months: 80%
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% of patients with duration above 12 months: 70%
The median time to response was1,2,3:
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2.8 months (range: 2.1, 8.8) in KEYNOTE-087
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2.8 months (range: 2.4, 8.6) in KEYNOTE-013
The median PFS was1,2,3:
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11.3 months (95% CI: 10.8, not reached) in KEYNOTE-087
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11.4 months (95% CI: 4.9, 27.8) in KEYNOTE-013
The OS rate was1,2,3:
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99.5% after 6 months in KEYNOTE-087
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100% after 6 months in KEYNOTE-013
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97.6% after 12 months in KEYNOTE-087
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87.1% after 12 months in KEYNOTE-013
Urothelial carcinoma
Cisplatin Ineligible Patients with Urothelial Carcinoma
The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Keytruda (pembrolizumab) for advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy were based on one open-label, single-arm trial (KEYNOTE-0521,2,3). This study involved a total of 370 patients. Patients received KEYTRUDA 200 mg every 3 weeks until unacceptable toxicity or disease progression up to a maximum of 24 months1,2,3.
Results
Among the efficacy outcome measures were the overall response rate (ORR), and duration of response (DOR).
The ORR was1,2,3:
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29% (95% CI: 24, 34)
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Complete response: 7%
The median DOR was1,2,3:
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Not reached (range: 1.4+, 17.8+)
Previously treated urothelial carcinoma
The Food and Drug Administration (FDA), USA, European Medical Agency (EMA), European Union, and Therapeutic Goods Administration (TGA), Australia, approvals of Keytruda (pembrolizumab) for advanced or metastatic urothelial carcinoma in patients whose disease progressed on or after platinum-containing chemotherapy were based on one randomised, active-controlled trial (KEYNOTE-0451,2,3). This study involved a total of 542 patients. Patients received KEYTRUDA 200 mg every 3 weeks or chemotherapy (paclitaxel, docetaxel, or vinflunine) until unacceptable toxicity or disease progression up to a maximum of 24 months1,2,3.
Results
Among the efficacy outcome measures were the overall survival (OS), progression-free survival (PFS), and overall response rate (ORR).
The ORR was1,2,3:
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21% (95% CI: 16, 27) with Keytruda (pembrolizumab)
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Complete response: 7%
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11% (95% CI: 8, 16) with chemotherapy
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Complete response: 3%
The median OS was1,2,3:
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10.3 months (95% CI: 8.0, 11.8) with Keytruda (pembrolizumab)
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%deaths: 57%
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7.4 months (95% CI 6.1, 8.3 ) with chemotherapy
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%deaths: 66%
The median PFS was1,2,3:
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2.1 months (95% CI: 2.0, 2.2) with Keytruda (pembrolizumab)
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3.3 months (95% CI: 2.3, 3.5) with chemotherapy
MSI-H Cancer
The Food and Drug Administration (FDA), USA, approval of Keytruda (pembrolizumab) for Microsatellite Instability-High Cancer (MSI-H) or mismatch repair deficient (dMMR) solid tumours were based on 5 studies (KEYNOTE-016, KEYNOTE-164, KEYNOTE-012, KEYNOTE-028, KEYNOTE-158). These studies involved a total of 149 patients with MSI-H/dMMR solid tumours. Patients received either Keytruda (pembrolizumab) 200 mg every 3 weeks or Keytruda (pembrolizumab) 10 mg/kg every 2 weeks. Treatment continued until unacceptable toxicity or disease progression, or up to a maximum of 24 months2.
Results
Among the efficacy outcome measures were the overall response rate (ORR), and the duration of response2.
The ORR was2:
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39.6% (95% CI: 31.7, 47.9)
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complete response rate: 7.4%
The median DOR was2:
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Not reached (range: 1.6+, 22.7+ months)
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78% of patients had DOR or more than 6 months
Gastric Cancer
The Food and Drug Administration (FDA), USA, approval of Keytruda (pembrolizumab) for gastric cancer were based on one non-randomised, open-label studies (KEYNOTE-059). These studies involved a total of 259 patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma who progressed on at least 2 prior systemic treatments for advanced disease. Patients received KEYTRUDA 200 mg every 3 weeks until unacceptable toxicity or disease progression or up to 24 months2.
Among the 259 patients, 55% (n = 143) had tumours that expressed PD-L1 with a combined positive score (CPS) of greater than or equal to 1 and microsatellite stable (MSS) tumor status or undetermined MSI or MMR status. The approval was based on the results of this subgroup.
Results
Among the efficacy outcome measures were the overall response rate (ORR), and the duration of response2.
The ORR was2:
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among the 143 patients subgroup
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13.3% (95% CI: 8.2, 20.0)
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complete response rate: 1.4%
The median DOR was2:
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among the 143 patients subgroup
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Not reached (range: 2.8+, 19.4+ months)
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26% of patients had DOR or more than 6 months
References
1. Summary of Product Characteristics [EMA]: Keytruda (pembrolizumab) [PDF]
Merck, May 2017.
2. Summary of Product Characteristics [FDA]: Keytruda (pembrolizumab) [PDF]
Merck, Nov 2017.
3. Summary of Product Characteristics [TGA]: Keytruda (pembrolizumab) [PDF]
Merck, EMA, Jan 2018.
Keytruda (pembrolizumab) treatment costs
The cost for a monthly or yearly treatment of Keytruda (pembrolizumab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (1 vial of powder for infusion).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Keytruda (pembrolizumab) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Keytruda (pembrolizumab) price and additional costs
The price of Keytruda (pembrolizumab)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
Our Named Patient support fee
TheSocialMedwork provides access to Keytruda (pembrolizumab) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
Shipping costs
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
You can read a detailed overview of prices and costs here.
Payment methods when you buy Keytruda (pembrolizumab)
When you buy Keytruda (pembrolizumab), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Keytruda (pembrolizumab) reimbursement
It might be possible for you to claim the cost of Keytruda (pembrolizumab) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping. For more details, please see our article on cold chain delivery.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Four steps to access the medicines you need
How and where to access and buy Keytruda: You can access Keytruda from TheSocialMedwork if the drug has not been approved or is not available in your country.
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Step 1
You send a request for your medicine online
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
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Step 2
We verify your prescription and medical details
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
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Step 3
We source your medicine
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
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Step 4
We deliver your medicine
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
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Looking for more information? Download your free guide on: “How to import a medicine”.
Select your preferred country and input your email to receive a step by step guide on how we can help you legally and safely import a medicine that is not approved in your country.
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+31 20 808 4414About us
We are TheSocialMedwork, a registered medical intermediary that helps you access elsewhere approved medicines, no matter where you live. To date, we have assisted patients in over 80 countries to access thousands of life-improving medicines.
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Disclaimer
Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.
