Bristol-Myers Squibb Provides Update on the Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer Patients with Tumor Mutational Burden =10 mut/Mb
Bristol-Myers Squibb Company (BMY)
Last bristol-myers squibb company earnings: 2/6 07:05 am
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Source: Business Wire
New analysis submitted to U.S. Food and Drug Administration (FDA) constitutes a major amendment to the Company’s supplemental Biologics License Application (sBLA) PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) 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
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BMY
Earnings
- 2/2/24 - Beat
BMY
Sec Filings
- 4/22/24 - Form DEFA14A
- 4/2/24 - Form 4
- 4/2/24 - Form 4
- BMY's page on the SEC website