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Pembrolizumab (EU)
Pembrolizumab (EU) is a PD-1 inhibitor Small molecule drug developed by Amgen. 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®.
Pembrolizumab is a monoclonal antibody that blocks PD-1 on immune cells, allowing them to recognize and attack cancer cells.
Pembrolizumab is a programmed cell death protein 1 inhibitor used to treat various conditions, including non-squamous non-small cell lung cancer, melanoma, and metastatic non-small cell lung cancer. It is classified as an inhibitor and is an antibody-based treatment.
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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. -
Big-pharma sponsor
+3.0pp
Amgen is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 (EU) |
|---|---|
| Also known as | Keytruda® |
| Sponsor | Amgen |
| 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 cells, preventing interaction with its ligands PD-L1 and PD-L2 on tumor cells. This blockade releases the 'brakes' on the immune system, restoring T cell activation, proliferation, and anti-tumor function. By reinvigorating exhausted T cells, pembrolizumab enables durable immune responses against cancer.
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
- Diarrhea
- Nausea
- Decreased appetite
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathy (thyroiditis, adrenalitis)
- Rash
Key clinical trials
- A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study) (PHASE3)
- A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (PHASE3)
- A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma (PHASE1)
- A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer (PHASE3)
- A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (PHASE3)
- A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy (PHASE1)
- A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer (PHASE3)
- A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer (PHASE3)
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 (EU) CI brief — competitive landscape report
- Pembrolizumab (EU) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Pembrolizumab (EU)
What is Pembrolizumab (EU)?
How does Pembrolizumab (EU) work?
What is Pembrolizumab (EU) used for?
Who makes Pembrolizumab (EU)?
Is Pembrolizumab (EU) also known as anything else?
What drug class is Pembrolizumab (EU) in?
What development phase is Pembrolizumab (EU) in?
What are the side effects of Pembrolizumab (EU)?
What does Pembrolizumab (EU) target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Amgen — 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®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing