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PF-06438179
PF-06438179 is a PD-1 inhibitor Biologic drug developed by Pfizer. It is currently in Phase 3 development for Non-small cell lung cancer, Melanoma. Also known as: Infliximab-Pfizer.
PF-06438179 is a small molecule inhibitor of the PD-1 receptor.
PF-06438179 is a small molecule inhibitor of the PD-1 receptor. Used for Non-small cell lung cancer, Melanoma.
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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
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-06438179 |
|---|---|
| Also known as | Infliximab-Pfizer |
| 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-06438179 prevents the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby releasing the brakes on T-cell activation and proliferation, leading to enhanced anti-tumor immune responses.
Approved indications
- Non-small cell lung cancer
- Melanoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Hyperthyroidism
Key clinical trials
- A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02). (PHASE3)
- A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01) (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:
- PF-06438179 CI brief — competitive landscape report
- PF-06438179 updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about PF-06438179
What is PF-06438179?
How does PF-06438179 work?
What is PF-06438179 used for?
Who makes PF-06438179?
Is PF-06438179 also known as anything else?
What drug class is PF-06438179 in?
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What are the side effects of PF-06438179?
What does PF-06438179 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
- Indication: Drugs for Melanoma
- Also known as: Infliximab-Pfizer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing