FDA Advisory Committee Votes in Favor of Bristol Myers Squibb's and 2seventy bio's Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy [Yahoo! Finance]
2seventy bio, Inc. (TSVT)
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Source: Yahoo! Finance
and Switzerland and received a positive CHMP Opinion by the European Medicines Agency based on KarMMa-3 PRINCETON, N.J. & CAMBRIDGE, Mass., March 15, 2024 BUSINESS WIRE Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival. The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population. The FDA has not yet assigned a new target action date for review of the sBLA. "We are extremely pleased with the positive outcome of the ODAC meeting, which reco
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- U.S. FDA Approves Bristol Myers Squibb and 2seventy bio's Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy [Yahoo! Finance]Yahoo! Finance
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