BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Bristol-Myers Squibb's Opdivo (nivolumab) for various cancer indications, including melanoma, NSCLC, RCC, cHL, SCCHN, urothelial carcinoma, MSI-H/dMMR metastatic colorectal cancer, and hepatocellular carcinoma. The report covers extensive efficacy data (overall survival, progression-free survival, overall response rate) from numerous clinical trials (e.g., CHECKMATE-037, -066, -067, -238, -017, -057, -025, -205, -039, -141, -275, -142, -040). It thoroughly analyzes Opdivo's safety profile, both as a monotherapy and in combination with ipilimumab, focusing on immune-mediated adverse reactions, their incidence, onset, and management. The report also supports the approval of new dosage regimens, specifically the 480 mg every four-week regimen, and extended 30-minute infusion times, based on pharmacokinetic modeling, exposure-response relationships, and comparable efficacy and safety to existing schedules.
Key findings — cited to the page
| Grade 3 or 4 adverse reactions (Opdivo plus ipilimumab) | 72 % | CHECKMATE-067 · p.33 |
| fatigue/asthenia (Grade 3-4) | 5 % | CHECKMATE-017 and CHECKMATE-057 · p.38 |
| Grade 3 and 4 adverse reactions with Opdivo | 41 % | CHECKMATE-066 · p.31 |
| diarrhea (Grade 3 and 4) | 3.4 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (Opdivo) | 25 % | CHECKMATE-238 · p.35 |
| fatigue/asthenia (Grade 1-4) | 48 % | CHECKMATE-017 and CHECKMATE-057 · p.38 |
| Nausea (all grades) | 22 % | CHECKMATE-275 · p.47 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| Grade 3 or higher acute GVHD incidence after allogeneic HSCT | 29 % | · p.26 |
| gamma-glutamyltransferase increase (Grade 3 and 4) | 3.9 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (Opdivo monotherapy) | 44 % | CHECKMATE-067 · p.33 |
| Increased ALT (grades 3-4) | 3.4 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
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 →