Bristol-Myers Squibb Co (NYSE:BMY) shares fell almost 5% after the company announced that a Food and Drug Administration (FDA) decision on the use of its blood cancer therapy Abecma, developed with partner 2seventy bio, has been delayed.
The companies said Monday that they have been informed by the FDA that a decision on their supplemental Biologics License Application (sBLA) for Abecma for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (RRMM) will not be made by the Prescription Drug User Fee Act target action date of December 16, 2023.
They said the FDA’s Oncologic Drugs Advisory Committee will meet to review data supporting the sBLA at a yet-to-be-confirmed date.
The application is supported by data from the Phase 3 KarMMa-3 study which demonstrated a statistically significant improvement in progression-free survival compared to standard regimens, the companies said.
Abecma has already been approved by the regulator for adult patients with triple-class exposed RRMM after four or more prior lines of therapy.
Bristol-Meyers Squibb shares were down 4.9% at US$48.35 shortly before the opening bell in New York on Monday and 2seventy bio shares fell 13.1% to US$1.85.
Also pressuring Bristol-Meyers Squibb shares was the news that German drugmaker Bayer AG (ETR:BAYN, OTC:BAYZF) has canned a late-stage trial of an experimental blood thinner which has cast doubt over the company’s similar drug in development, milvexian.
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