Bristol-Myers not asking for faster Opdivo/Yervov approval for first-line lung cancer in U.S.
January 20, 2017Bristol-Myers Squibb said on Thursday that it won’t seek an accelerated approval for the combination of Opdivo plus Yervoy in first-line lung cancer in the U.S.
The company based its decision on a review of so far known data.
Bristol said it won’t give more details because of the integrity of ongoing registrational studies.
Reuters has cited Jeffries analyst Jeffrey Holford as saying in a research note that he expected Bristol to have its combination approved in the second half of 2018.
Opdivo harness the body’s own immune system to help restore anti-tumor immune response. Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. Opdivo clinical development program has enrolled more than 25,000 patients.
FDA has approved Opdivo for several different indications, in single use or in a combination.
