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 for Bristol-Myers Squibb's Opdivo (nivolumab) details its regulatory history, multiple indications across various cancer types (melanoma, NSCLC, RCC, Hodgkin lymphoma, etc.), and dosage regimens, including the proposed 480 mg Q4W regimen. The report comprehensively outlines Opdivo's safety profile as monotherapy and in combination with ipilimumab, focusing on immune-mediated adverse reactions, their incidence, onset, and management. Efficacy data, including overall survival, progression-free survival, and overall response rates, are presented from numerous clinical trials (e.g., CHECKMATE series), often comparing Opdivo to standard treatments. The 480 mg Q4W regimen is deemed to have comparable efficacy and safety to existing regimens, with no new safety concerns identified.
Key findings — cited to the page
| Grade 3 or 4 adverse reactions (OPDIVO arm) | 44 % | CHECKMATE-067 · p.33 |
| Leukopenia (all grades) | 38 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| gamma-glutamyltransferase increase (grades 3-4) | 3.9 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (OPDIVO plus ipilimumab arm) | 72 % | CHECKMATE-067 · p.33 |
| immune-mediated pneumonitis (Grade 3) | 1 | CHECKMATE-205 and CHECKMATE-039 · p.44 |
| immune-mediated pneumonitis (Grade 2) | 12 | CHECKMATE-205 and CHECKMATE-039 · p.44 |
| Grade 3 or higher acute GVHD incidence after allogeneic HSCT | 29 % | · p.26 |
| Grade 3 and 4 adverse reactions | 41 % | CHECKMATE-066 · p.31 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| diarrhea (grades 3-4) | 3.4 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions | 25 % | CHECKMATE-238 · p.35 |
| Leukopenia (grades 3-4) | 4.5 % | 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 →