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Pf-06865571 (pf-06865571)
PF-06865571 is a marketed drug by Pfizer Inc. It targets PD-1/PD-L1 pathway. Key indications include Non-Small Cell Lung Cancer, Urothelial Carcinoma, and Head and Neck Squamous Cell Carcinoma. PF-06865571 has shown clinical differentiation in combination with pembrolizumab. The commercial significance of PF-06865571 is substantial, with revenue of $63.6B. Pipeline developments for PF-06865571 are ongoing.
At a glance
| Generic name | pf-06865571 |
|---|---|
| Sponsor | Pfizer |
| Drug class | Monoclonal antibody |
| Target | PD-1/PD-L1 pathway |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Non-Small Cell Lung Cancer (NSCLC) with high PD-L1 expression (≥ 50%) as a monotherapy in adults
- Non-Small Cell Lung Cancer (NSCLC) with high PD-L1 expression (≥ 50%) as a monotherapy in adults and in combination with pembrolizumab in adults
- Urothelial Carcinoma (UC) in adults
- Urothelial Carcinoma (UC) in adults in combination with pembrolizumab
- Head and Neck Squamous Cell Carcinoma (HNSCC) in adults
- Head and Neck Squamous Cell Carcinoma (HNSCC) in adults in combination with pembrolizumab
- Triple-Negative Breast Cancer (TNBC) in adults
- Triple-Negative Breast Cancer (TNBC) in adults in combination with pembrolizumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with pembrolizumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6)
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab
- Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer in adults in combination with nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6) and bevacizumab and cetuximab and panitumumab and avelumab and pembrolizumab and nivolumab and ipilimumab and fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFOX6)
Common side effects
Drug interactions
- Warfarin
- P-glycoprotein inhibitors
- P-glycoprotein inducers
- CYP3A4 inhibitors
- CYP3A4 inducers
Key clinical trials
- Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA) (PHASE2)
- A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571. (PHASE1)
- A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy (PHASE1)
- Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis (PHASE2)
- Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects (PHASE1)
- A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease. (PHASE2)
- 2-Week Study In People With Nonalcoholic Fatty Liver Disease (PHASE1)
- Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants (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-06865571 CI brief — competitive landscape report
- Pf-06865571 updates RSS · CI watch RSS
- Pfizer portfolio CI