Posted by Michael Wonder on 20 Oct 2018
Bristol-Myers Squibb provides update on the ongoing regulatory review of Opdivo plus low dose Yervoy in first-line lung cancer patients with tumour mutational burden ≥10 mut/Mb
19 October 2018 - New analysis submitted to U.S. FDA constitutes a major amendment to the Company’s supplemental biologics license application.
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 tumour 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 CHMP requested additional information from CheckMate-227, including an overall survival 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.
