Bristol-Myers Squibb Company — Opdivo FDA Review (BLA761381, ORIG 1, 2024)
Bristol-Myers Squibb Company · 2024 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of Bristol-Myers Squibb's Biologics License Applications (BLA 761381 and 761429) for Opdivo (nivolumab and hyaluronidase-nvhy) subcutaneous injection recommends traditional approval for various solid tumor indications, including advanced Renal Cell Carcinoma, Melanoma, and NSCLC, while maintaining Accelerated Approval for HCC and dMMR/MSI-H CRC. The review confirms pharmacokinetic non-inferiority and comparable safety of the subcutaneous formulation to the intravenous formulation, primarily based on studies CA20967T and CA2098KX. Key findings include non-inferiority in objective response rates and similar safety profiles, with injection site reactions being the main difference. Postmarketing requirements include pediatric investigations and commitments for accelerated approval indications.
Key findings — cited to the page
| All-causality AEs leading to DC (Any Grade) | 25 (10.1%) | CA20967T · p.123 |
| Drug-related AEs leading to DC (Any Grade) | 10 (4.0%) | CA20967T · p.123 |
| All-causality SAEs (Any Grade) | 71 (29.0%) | CA20967T · p.122 |
| Drug-related SAEs (Grade 3-4) | 16 (6.5%) | CA20967T · p.123 |
| All-causality AEs leading to DC (Any Grade) | 29 (11.8%) | CA20967T · p.123 |
| All-causality AEs leading to DC (Grade 3-4) | 21 (8.6%) | CA20967T · p.123 |
| All-causality SAEs (Any Grade) | 69 (27.9%) | CA20967T · p.122 |
| All-causality SAEs (Grade 3-4) | 52 (21.1%) | CA20967T · p.122 |
| All-causality SAEs (Grade 3-4) | 56 (22.9%) | CA20967T · p.122 |
| Drug-related SAEs (Any Grade) | 17 (6.9%) | CA20967T · p.123 |
| All-causality AEs leading to DC (Grade 3-4) | 18 (7.3%) | CA20967T · p.123 |
| Drug-related AEs leading to DC (Grade 3-4) | 6 (2.4%) | CA20967T · p.123 |
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 →