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Pembrolizumab (US)
Pembrolizumab (US) is a Small molecule drug developed by Amgen. It is currently in Phase 3 development. Also known as: Keytruda®.
Pembrolizumab is a monoclonal antibody that blocks the PD-1 receptor, preventing cancer cells from evading the immune system.
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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). -
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 (US) |
|---|---|
| Also known as | Keytruda® |
| Sponsor | Amgen |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, pembrolizumab releases the brakes on the immune system, allowing T cells to recognize and attack cancer cells. This mechanism is known as immune checkpoint inhibition. Pembrolizumab is designed to work in patients with tumors that have high levels of PD-L1, a protein that can bind to PD-1 and prevent T cell activation.
Approved indications
Common side effects
Key clinical trials
- Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer (PHASE2)
- 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 Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors (PHASE1)
- 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 Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants (PHASE1)
- A Study to Evaluate PK, Efficacy, and Safety of BAT3306 Plus Chemo and Compare With Keytruda®(EU/US) in Participants With IV nqNSCLC (PHASE3)
- Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC) (PHASE1)
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 (US) CI brief — competitive landscape report
- Pembrolizumab (US) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Pembrolizumab (US)
What is Pembrolizumab (US)?
How does Pembrolizumab (US) work?
Who makes Pembrolizumab (US)?
Is Pembrolizumab (US) also known as anything else?
What development phase is Pembrolizumab (US) in?
Related
- Manufacturer: Amgen — full pipeline
- Also known as: Keytruda®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing