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Pembrolizumab (MK-3475)
Pembrolizumab (MK-3475) is a PD-1 inhibitor Small molecule drug developed by Memorial Sloan Kettering Cancer Center. It is currently in Phase 3 development for Metastatic melanoma, Non-small cell lung cancer (NSCLC), Head and neck squamous cell carcinoma. Also known as: KEYTRUDA®, MK-3475, Keytruda.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on T cells, allowing the immune system to recognize and attack cancer cells.
Pembrolizumab is an antibody that inhibits the programmed cell death protein 1 (PD-1), a protein involved in the regulation of the immune system. It is used to treat various types of cancer, including gastric cancer, gastroesophageal junction cancer, sarcoma, and gastroesophageal adenocarcinoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Pembrolizumab (MK-3475) |
|---|---|
| Also known as | KEYTRUDA®, MK-3475, Keytruda |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Pembrolizumab binds to programmed death receptor 1 (PD-1) on T lymphocytes, preventing interaction with its ligands PD-L1 and PD-L2 on tumor cells. This blockade releases the 'brakes' on anti-tumor immunity, restoring T cell proliferation, activation, and cytotoxic function. By reinvigorating exhausted T cells, pembrolizumab enables durable anti-tumor responses.
Approved indications
- Metastatic melanoma
- Non-small cell lung cancer (NSCLC)
- Head and neck squamous cell carcinoma
- Hodgkin lymphoma
- Urothelial carcinoma
- Gastric cancer
- Cervical cancer
- Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors
Common side effects
- Fatigue
- Decreased appetite
- Nausea
- Diarrhea
- Immune-related pneumonitis
- Immune-related hepatitis
- Immune-related colitis
- Hypothyroidism
- Rash
Key clinical trials
- Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
- Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) (PHASE2, PHASE3)
- Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial (PHASE2)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma (PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) (PHASE1)
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pembrolizumab (MK-3475) CI brief — competitive landscape report
- Pembrolizumab (MK-3475) updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI
Frequently asked questions about Pembrolizumab (MK-3475)
What is Pembrolizumab (MK-3475)?
How does Pembrolizumab (MK-3475) work?
What is Pembrolizumab (MK-3475) used for?
Who makes Pembrolizumab (MK-3475)?
Is Pembrolizumab (MK-3475) also known as anything else?
What drug class is Pembrolizumab (MK-3475) in?
What development phase is Pembrolizumab (MK-3475) in?
What are the side effects of Pembrolizumab (MK-3475)?
What does Pembrolizumab (MK-3475) target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Memorial Sloan Kettering Cancer Center — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic melanoma
- Indication: Drugs for Non-small cell lung cancer (NSCLC)
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: KEYTRUDA®, MK-3475, Keytruda
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing