BRISTOL MYERS SQUIBB — Opdivo FDA Summary Review (NDA/BLA 125554, 2015)
Bristol-Myers Squibb Company · 2015 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
The FDA recommended accelerated approval for Bristol Myers Squibb's Opdivo (nivolumab) for metastatic melanoma. This decision was based on an interim analysis of Study CA209037, demonstrating a 31.7% durable objective response rate in previously treated patients. The report details Opdivo's safety profile, including common Grade 3/4 adverse events and autoimmune-mediated toxicities, which were deemed manageable. The regulatory history and post-marketing requirements are also outlined, supporting the drug's efficacy and manageable safety for this indication.
Key findings — cited to the page
| Grade 3 or 4 adverse reactions (nivolumab-treated) | 20% | · p.4 |
| Approval pathway | accelerated approval | Opdivo (nivolumab) · p.3 |
| Partial Responses | 34 | Protocol CA209037 · p.3 |
| N enrolled in interim analysis | 120 patients | Protocol CA209037 · p.3 |
| Overall Response Rate (ORR) | 31.7% | Protocol CA209037 · p.3 |
| Complete Responses | 4 | Protocol CA209037 · p.3 |
| Trial design | interim, non-comparative analysis of an ongoing, randomized (2:1), open-label study | Protocol CA209037 · p.3 |
| Patients with ongoing responses | 33 | Protocol CA209037 · p.3 |
| Patients with ongoing responses > 6 months | 13 | Protocol CA209037 · p.3 |
| Ipilimumab approval date | March 25, 2011 | ipilimumab (Yervoy) · p.5 |
| IND 100052 sponsorship transfer date | January 27, 2010 | IND 100052 · p.6 |
| Approval recommendation | approved | Opdivo (nivolumab) · p.3 |
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 →