What Is Keytruda (Pembrolizumab)? Cancers It Is Used For, Effects, and Side Effects
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What Is Keytruda?
With the active ingredient pembrolizumab, Keytruda is a drug designed to enhance the immune system's ability to detect cancer cells and to mount an attack against cancer cells. It is an immunotherapy. Research on pembrolizumab began in 2006. Its developers, Gregory Carven, Hans Van Eenennaam, and John Dulos, were named inventors of the year in 2016 by the Intellectual Property Owners Education Foundation.
Keytruda Price
June 2026 is the date as of which the price of Keytruda 100 mg / 4 ml was set at 88,783.52 TL.
In 1 cycle administered every 3 weeks, 200 ml (2 boxes) is used, meaning that 1 treatment cycle costs 177,567,04 TL.
- This information does not replace a doctor/pharmacist and is intended as general information. Consult your pharmacist about prices.
What Is Keytruda's Mechanism of Action?
Keytruda acts on the immune system's T cells by binding to their PD-1 receptor. PD-1 is a surface molecule that suppresses immune cells, and therefore the immune system, when it binds to its stimulating molecules. Keytruda binds to the PD-1 receptor, blocking the interaction of both stimulating molecules PD‑L1 and PD‑L2 with PD-1, helping restore the T-cell response and allowing the immune system to be active. Thus, the immune system can continue functioning. However, this method does not work in all cancer types because cancer cells also use cellular mechanisms other than this checkpoint to hide from the immune system.
What Is Keytruda Used For?
Keytruda (active ingredient pembrolizumab) enhances the immune system's ability to fight cancer cells and is an immunotherapy drug. It works specifically by targeting an immune checkpoint called PD-1 (programmed death-1). Normally, the PD-1 pathway is a braking mechanism that prevents the body's immune cells from overreacting. However, some tumors use this pathway to prevent immune cells from attacking them. Keytruda blocks the PD-1 receptor, removing this brake and enabling the immune system to recognize and destroy cancer cells.
The drug is used in many cancer types. These include:
- Lung cancer
- Melanoma (skin cancer)
- Head and neck squamous cell cancers
- Gastric and gastroesophageal junction cancers
- Kidney cancer (RCC)
- Bladder (urothelial) cancer
- Cervical and endometrial cancer
- Colorectal cancer (types with high microsatellite instability – MSI-H or dMMR)
- Hepatocellular carcinoma (liver cancer)
- Esophagus and food-pipe cancers
- Certain tumor types in young children (for example, Hodgkin lymphoma)
📜 FDA Approval Timeline
- 2014: First FDA approval for metastatic melanoma (progression after ipilimumab or a BRAF inhibitor).
- 2015: Second-line treatment approval for PD-L1-positive advanced lung cancer (KHDAK).
- 2016: Approvals for classical Hodgkin lymphoma and head and neck squamous cell cancers (HNSCC).
- 2017:
- First-line treatment approval in PD-L1-positive NSCLC.
- MSI-H or dMMR solid tumors received the first “tissue-agnostic” approval.
- Approval for bladder (urothelial) and gastric/gastroesophageal junction adenocarcinoma.
- 2018:
- Cervical cancer (PD-L1-positive advanced cases).
- Hepatocellular carcinoma (HCC), in patients with progression after sorafenib.
- Approval of combination with chemotherapy in NSCLC (first line).
- 2019:
- Third-line treatment for small-cell lung cancer (SCLC) (subsequently withdrawn).
- First-line approval in MSI-H colorectal cancer.
- Expansion of the indication to solid tumors with high tumor mutational burden (TMB-high ≥10 mut/Mb).
- 2020:
- Second “tissue-agnostic” approval in tumors with high tumor mutational burden (TMB-high).
- PD-L1-positive approval for esophageal and gastroesophageal junction cancers.
- 2021:
- Approval in PD-L1-positive cases in combination with chemotherapy for Triple-Negative Breast Cancer (TNBC) (KEYNOTE-355).
- Combination approval with lenvatinib or aksitinib for renal cell carcinoma (RCC).
- Expansion of the indication in endometrial cancer (MSI-H/dMMR).
- 2022:
- Voluntary withdrawal of the SCLC approval.
- New combinations in MSI-H gastrointestinal and gynecological cancers.
- 2023:
- Approval for adjuvant (postoperative) NSCLC and RCC.
- Approval in early-stage TNBC treatment as a neoadjuvant + adjuvant combination (KEYNOTE-522).
- 2024:
- Approval for adjuvant use with chemoradiotherapy in cervical cancer.
- First-line combination approval with trastuzumab + chemotherapy for gastroesophageal junction adenocarcinoma (KEYNOTE-811).
🔍 Clinical Significance
Since its first melanoma approval in 2014, Keytruda has received approval in more than 20 cancer types, reaching the broadest range of indications among PD-1 inhibitors. Thanks to its “tissue-agnostic” approvals, cancer treatment has entered an era of selecting treatment based not only on the organ but on the molecular profile.
Is Keytruda Covered by SGK Reimbursement in Türkiye?
- For patients with metastatic disease, PD-L1 expression <50% (0%-49%), an ECOG performance score of 0-1, adequate cardiac, renal, and hepatic function, no active brain metastases, no EGFR, ALK, or ROS mutations, and no concurrent immunosuppressive or corticosteroid treatment, non-squamous non-small-cell lung cancer treatment in the first line is reimbursed under a report.
Explanation: Treatment is started as 4 courses in combination with a platinum and pemetrekset chemotherapy regimen. During continuation, when pembrolizumab is used in combination with pemetrekset for a maximum of 35 courses including the initial courses in 3-week cycles, or a maximum of 17 courses including the initial courses in 6-week cycles, its cost is covered by the Institution. - For patients with PD-L1 expression <50% (0%-49%), an ECOG performance score of 0-1, adequate cardiac, renal, and hepatic function, no active brain metastases, and no concurrent immunosuppressive and corticosteroid treatment, pembrolizumab use in metastatic squamous non-small-cell lung cancer as first-line treatment is reimbursed under a report.
Explanation: Treatment is started as 4 courses in combination with a karboplatin and paklitaksel chemotherapy regimen. During continuation, when pembrolizumab is used as monotherapy for a maximum of 35 courses including the initial courses in 3-week cycles, or a maximum of 17 courses including the initial courses in 6-week cycles, its cost is covered by the Institution. - For patients with an ECOG performance score of 0-1, adequate cardiac, renal, and hepatic function, no active brain metastases, and no concurrent immunosuppressive or corticosteroid treatment, in metastatic non-small-cell lung cancer, where PD-L1 expression is 50% or above, use as first-line monotherapy is reimbursed under a report.
Explanation: For metastatic non-squamous non-small-cell lung cancer, the report must state that there are no EGFR, ALK, or ROS mutations. - For locally advanced/early-stage disease, an ECOG performance score of 0-1, and a high risk of recurrence (tumor size ≥2 cm or axillary lymph-node positivity), adults with triple-negative breast cancer have treatment reimbursed under a report when it is used as neoadjuvant treatment in combination with anthracycline- and karboplatin-containing chemotherapy.
Explanation: Pembrolizumab is used in neoadjuvant treatment every 3 weeks at 200 mg for 8 courses, or every 6 weeks at 400 mg for 4 courses. - With PD-L1(+) CPS ≥ 10 on a validated test, metastatic or unresectable locally recurrent triple-negative breast cancer first-line treatment is reimbursed under a report when it is used in combination with chemotherapy.
- As monotherapy or in combination with platinum and 5-florourasil (5-FU) chemotherapy, in adults with an ECOG performance score of 0-1 and tumors expressing PD-L1 with a combined positive score (CPS) ≥ 1%, metastatic or unresectable recurrent non-nasopharyngeal squamous cell carcinoma of the head and neck first-line treatment is reimbursed under a report.
Türkiye Authorization and Therapeutic Indications
Keytruda received authorization through Merck Sharp Dohme İlaçları Ltd.Şti. on 06.06.2016.
Melanoma: It is indicated for patients with ECOG PS 0-1 whose unresectable or metastatic malignant melanoma has progressed after at least one line of systemic treatment, and for Stage IIB, IIC adjuvant treatment.
KHDAK: It is indicated as monotherapy or a combination in first-line treatment according to PD-L1 status in patients with mutation-free metastatic KHDAK and ECOG PS 0-1.
Urothelial Carcinoma: It is indicated in patients with progression after platinum-containing treatment or PD-L1-positive patients who are unsuitable for sisplatin.
Other Indications: There are approved uses for SHBBK, RCC, Classical Hodgkin Lymphoma, Esophageal Carcinoma, mCRC, TNBC, and MSI-H/dMMR Solid Tumors.
What Are Keytruda's Dose, Administration Duration, and Technique?
The dose of Keytruda every 3 weeks is 200 mg or 2 mg/kg; the dose every 6 weeks is 400 mg. These cycles are called courses. These courses are generally continued until the drug stops working, an unacceptable side effect occurs, or, if no cancer progression is observed, for up to 24 months. In adjuvant treatment, this period is usually 12 months.
Keytruda is administered by intravenous infusion (into a vein) for at least 30 minutes on the first day of each course. It is usually administered in day-treatment outpatient centers.
What Are Keytruda's Side Effects?
Diarrhea, nausea, itching, skin rash, fatigue, joint pain, a reduction in red blood cell count, thyroid problems, shortness of breath, cough, and infusion reactions are the most commonly reported side effects.
In the graph below, you can see the onset and resolution times of the most common side effects of immunotherapies:
Monitoring and Points to Note
Monitoring: Periodic complete blood counts, metabolic panels, and thyroid function tests should be performed before and during treatment. Imaging (MRI, BT, PET) is repeated periodically according to the doctor's recommendation.
- Corticosteroids may be needed in the event of severe immune-system reactions (lungs, intestines, liver, etc.).
- Vitiligo may occur in 25% of melanoma patients (onset is on day 126 on average).
- All other medicines used must be reported to the doctor because of the risk of interactions.
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