BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
In May 2020, Bristol-Myers Squibb's Yervoy (ipilimumab) and Opdivo (nivolumab) received FDA approval for new indications. Specifically, Yervoy, in combination with nivolumab and platinum-based chemotherapy, was approved for the first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. Opdivo received a similar approval for the same indication and combination therapy. The approval was based on robust efficacy data from clinical trials, notably Study CA2099LA (CheckMate-9LA), which demonstrated significant improvements in overall survival, progression-free survival, and objective response rates for the combination therapy compared to chemotherapy alone. The report details the recommended dosing schedules for Yervoy and Opdivo across various cancer types and provides extensive information on their safety profiles, including immune-mediated adverse reactions, their incidence, time to onset, and management strategies. The multidisciplinary FDA review concluded a favorable risk-benefit profile, leading to regular approval for this combination therapy.
Key findings — cited to the page
| median time to onset for Grade 3 to 4 enterocolitis | 1.1 months | CA184-029 · p.24 |
| Grade 3 to 4 immune-mediated hepatitis | 11 % | CA184-029 · p.26 |
| median time to onset of Grade 3 to 5 enterocolitis | 1.7 months | MDX010-20 · p.24 |
| Grade 2 immune-mediated enterocolitis | 14 % | CA184-029 · p.24 |
| severe, life-threatening, or fatal hepatotoxicity (Grade 3 to 5) | 2 % | MDX010-20 · p.26 |
| moderate hepatotoxicity (Grade 2) | 2.5 % | MDX010-20 · p.26 |
| severe, life-threatening, or fatal immune-mediated enterocolitis (Grade 3 to 5) | 7 % | MDX010-20 · p.24 |
| moderate immune-mediated enterocolitis (Grade 2) | 5 % | MDX010-20 · p.24 |
| median time to onset of Grade 2 enterocolitis | 1.4 months | MDX010-20 · p.24 |
| Grade 3 to 5 immune-mediated enterocolitis | 16 % | CA184-029 · p.24 |
| median time to onset for Grade 2 enterocolitis | 1.1 months | CA184-029 · p.24 |
| moderate Grade 2 immune-mediated hepatitis | 5 % | CA184-029 · p.26 |
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 →