BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA's review of Bristol-Myers Squibb's Opdivo (nivolumab), approved July 31, 2017, for various cancer indications, including accelerated approvals for melanoma, Hodgkin lymphoma, urothelial carcinoma, and MSI-H/dMMR metastatic colorectal cancer (mCRC), and standard approvals for NSCLC and renal cell carcinoma. The review details Opdivo's efficacy, demonstrating improved overall survival, progression-free survival, and objective response rates across numerous clinical trials (e.g., CHECKMATE-037, -066, -067, -017, -057, -025, -205, -039, -141, -275, CA209142). It thoroughly outlines the safety profile, including common and serious adverse events, particularly immune-mediated reactions like pneumonitis, colitis, and endocrinopathies, along with their incidence and management. Postmarketing requirements and commitments are also discussed.
Key findings — cited to the page
| patients who experienced a Grade 3-4 AE | 54 % | CA209142 · p.154 |
| patients who experienced a Grade 1-2 AE | 93 % | CA209142 · p.154 |
| patients who experienced a Grade 3-4 AE | 40 | CA209142 · p.154 |
| partial response rate by IRRC in all MSIH/dMMR mCRC patients | 30 % | CA209142 · p.139 |
| partial response rate by IRRC in patients who progressed after fluoropyrimidine, oxaliplatin and irinotecan | 26 % | · p.141 |
| patients who experienced a Grade 1-2 AE | 69 | CA209142 · p.154 |
| patients with Grade 3-4 fatigue | 4 | · p.160 |
| objective response rate (ORR) by IRRC in patients who progressed after fluoropyrimidine, oxaliplatin and irinotecan | 28 % | · p.141 |
| objective response rate (ORR) by IRRC in all MSIH/dMMR mCRC patients | 32 % | CA209142 · p.139 |
| complete response rate by IRRC in all MSIH/dMMR mCRC patients | 2.7 % | CA209142 · p.139 |
| complete response rate by IRRC in patients who progressed after fluoropyrimidine, oxaliplatin and irinotecan | 1.9 % | · p.141 |
| patients with edema (all grades) | 15 % | · p.160 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →