U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb?s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in First-Line Non-Small Cell Lung Cancer
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Application based on results from Part 1 of Phase 3 CheckMate -227 study
$BMY announces the FDA has accepted its application in first-line #lungcancer and granted priority review
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PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company?(NYSE: BMY) today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for?Opdivo?(nivolumab) in combination with?Yervoy?(ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020.
?The FDA?s acceptance of our application for?Opdivo?plus?Yervoy?represents an important milestone for patients with lung cancer in the United States, where, despite recent treatment advances, lung cancer remains the cause of more than 150,000 deaths each year,? said Sabine Maier, M.D., development lead, thoracic cancers, Bristol-Myers Squibb. ?Lung cancer is the third tumor type where the combination of?Opdivo?and?Yervoy?has demonstrated significant long-term overall survival benefit in a randomized Phase 3 trial, which further validates the immunologic rationale for dual Immuno-Oncology therapy.?
This application is based on data from Part 1 of the Phase 3 CheckMate -227 trial evaluating?Opdivo?plus?Yervoy?versus chemotherapy in patients with previously untreated NSCLC, in which the dual immunotherapy combination demonstrated significant improvement in overall survival versus chemotherapy alone. The safety profile of?Opdivo?plus?Yervoy?was consistent with previously reported studies and no new safety signals were observed.
About CheckMate -227
CheckMate -227 is a multi-part open-label Phase 3 trial evaluating?Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer across non-squamous and squamous tumor histologies:
- Part 1:
- Part 1a:?Opdivo?plus low-dose?Yervoy?or?Opdivo?monotherapy versus chemotherapy in patients whose tumors express PD-L1
- Part 1b:?Opdivo?plus low-dose?Yervoy?or?Opdivo?plus chemotherapy versus chemotherapy in patients whose tumors do not express PD-L1
- Part 2:?Opdivo?plus chemotherapy versus chemotherapy, regardless of PD-L1
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