Last reviewed · How we verify
PF-06462700
PF-06462700 is a PD-1 inhibitor Biologic drug developed by Pfizer. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma. Also known as: Brand name in the US: ATGAM.
PF-06462700 is a small molecule that targets the PD-1 receptor.
PF-06462700 is a small molecule that targets the PD-1 receptor. Used for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.
-
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
Pfizer 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 | PF-06462700 |
|---|---|
| Also known as | Brand name in the US: ATGAM |
| Sponsor | Pfizer |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, PF-06462700 blocks the interaction between PD-1 and its ligands, leading to the activation of T cells and an anti-tumor immune response.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Head and neck squamous cell carcinoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Hyperthyroidism
Key clinical trials
- A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia (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:
- PF-06462700 CI brief — competitive landscape report
- PF-06462700 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about PF-06462700
What is PF-06462700?
How does PF-06462700 work?
What is PF-06462700 used for?
Who makes PF-06462700?
Is PF-06462700 also known as anything else?
What drug class is PF-06462700 in?
What development phase is PF-06462700 in?
What are the side effects of PF-06462700?
What does PF-06462700 target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer, PD-L1 positive
- Indication: Drugs for Head and neck squamous cell carcinoma
- Also known as: Brand name in the US: ATGAM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing