Last reviewed 2026-04-20 · How we verify

Pf-06823859 (pf-06823859)

PF-06823859, a marketed drug by Pfizer Inc., is a monoclonal antibody targeting PD-1/PD-L1. It is used in the treatment of Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, and Locally Advanced or Metastatic Urothelial Carcinoma. The drug has shown clinical differentiation in patients with high PD-L1 expression and disease progression on or after platinum-containing chemotherapy. Its commercial significance is evident in its $21.2B revenue. The pipeline developments for PF-06823859 are not specified. As a PD-1/PD-L1 inhibitor, PF-06823859 has shown promise in treating various types of cancer.

At a glance

Approved indications

• Non-Small Cell Lung Cancer (NSCLC) with high PD-L1 expression (Tumor Proportion Score (TPS) ≥ 50%) as monotherapy (pembrolizumab in combination with pemetrexed and platinum (pemetrexed + platinum) in patients with a PD-L1 TPS ≥ 1% as determined by an FDA-approved test.
• Squamous Cell Carcinoma of the Head and Neck (SCCHN) with disease progression on or after platinum-containing chemotherapy.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy and have a PD-L1 combined positive score (CPS) ≥ 10 as determined by an FDA-approved test.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy and have a PD-L1 combined positive score (CPS) ≥ 10 as determined by an FDA-approved test in combination with axitinib.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy and have a PD-L1 combined positive score (CPS) ≥ 10 as determined by an FDA-approved test in combination with lenvatinib.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy and have a PD-L1 combined positive score (CPS) ≥ 10 as determined by an FDA-approved test in combination with pembrolizumab and lenvatinib.
• Locally Advanced or Metastatic Urothelial Carcinoma (UC) with disease progression during or following platinum-containing chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-containing chemotherapy in patients who are not eligible for platinum-containing chemotherapy and have a PD-L1 combined positive score (CPS) ≥ 10 as determined by an FDA-approved test in combination with pembrolizumab and lenvatinib in patients with a PD-L1 CPS ≥ 10 as determined by an FDA-approved test.

Common side effects

• Headache
• COVID-19
• Pruritus
• Fatigue
• Sinusitis
• SARS-CoV-2 test positive
• Diarrhoea
• Upper respiratory tract infection
• Cough
• Nasopharyngitis
• Abdominal pain
• Nausea

Drug interactions

• Warfarin
• P-glycoprotein inhibitors
• P-glycoprotein inducers
• CYP3A4 inhibitors
• CYP3A4 inducers

Key clinical trials

• A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms. (PHASE2)
• A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)] (PHASE3)
• An Extension Study for Participants Who Have Completed the Treatment Period of a Qualifying Parent Study (PHASE2)
• A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants (PHASE1)
• Investigation of Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single-Dose of PF-06823859 in Japanese Healthy Participants (PHASE1)
• A Study In Adults With Moderate To Severe Dermatomyositis (PHASE2)
• Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of Compound PF-06823859 (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Pf-06823859 CI brief — competitive landscape report
• Pf-06823859 updates RSS · CI watch RSS
• Pfizer portfolio CI