Biotech Values

[DewDiligence]

BMY—PDUFA date for CHECKMATE-227-based BLA is now 5/20/19—EU MAA also delayed:

https://www.businesswire.com/news/home/20181019005565/en/Bristol-Myers-Squibb-Update-Ongoing-Regulatory-Review-Opdivo

Bristol-Myers Squibb announced updates regarding regulatory actions by health authorities in the United States (U.S.) and European Union (EU) for the ongoing review of its applications for an indication in metastatic first-line non-small cell lung cancer with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). Both applications are based on data from Part 1 of the ongoing Phase 3 CheckMate -227 trial.

As part of the ongoing EU review process, the Committee for Medicinal Products for Human Use (CHMP) requested additional information from CheckMate -227, including an overall survival (OS) analysis of Opdivo plus Yervoy in patients who have TMB <10 mut/Mb. Bristol-Myers Squibb obtained agreement from the CHMP for an extension of the clock-stop for its type II variation application to address this first request for supplementary information. The Company previously announced the validation of the application in May 2018.

The Company submitted the OS analysis for the TMB <10 mut/Mb subgroup to the FDA. The FDA determined that the submission of this new information constituted a major amendment to the sBLA and notified the Company today that the review period was extended by three months with a new Prescription Drug User Fee Act goal date of May 20, 2019. The Company previously announced the application was accepted for review in June 2018.