BRISTOL-MYERS SQUIBB: U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ≥10 mut/Mb

Source: Bristol-Myers Squibb

Bristol-Myers Squibb issued the following announcement on June 21.

Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). The target FDA action date is February 20, 2019.

Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, commented, “Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients. We look forward to working with the FDA throughout the review process to bring this important treatment option to patients.”

The application was based on results from Part 1 of CheckMate -227, the first and only global Phase 3 study to evaluate an I-O/I-O regimen versus chemotherapy in a population of first-line NSCLC patients with TMB ≥10 mut/Mb, across squamous and non-squamous tumor histologies and the PD-L1 expression spectrum. These data were presented at the American Association for Cancer Research Annual Meeting 2018 and published in The New England Journal of Medicine.

Original source can be found here.

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