Bristol-Myers Squibb, 2seventy Bio Shares Fall as FDA Delays Decision on Cancer Drug

Shares of Bristol-Myers Squibb (BMY) and partner 2seventy bio (TSVT) slumped after the two companies announced that the Food and Drug Administration (FDA) would not make a decision on expanded use for their blood cancer treatment, Abecma, next month as originally planned.

The FDA was set to decide on Dec. 16 whether Abecma could be prescribed for those with earlier lines of triple-class exposed relapsed or refractory multiple myeloma. Regulators had already approved Abecma to treat adult patients with multiple myeloma after four or more previous treatments weren’t effective.

Bristol-Myers Squibb and 2seventy bio indicated they anticipate officials would be reviewing data related to the secondary endpoint of overall survival rates in their Phase 3 study of Abecma. They added they “looked forward to continuing discussions with the FDA,” as well as participating in the meeting of the FDA’s Oncologic Drug Advisory Committee that will be analyzing the results.?

A decision by Germany’s Bayer to end a Phase 3 trial of an experimental blood-thinning medicine because of lack of efficacy also raised concerns about the future of a similar medicine under development by Bristol-Myers Squibb and Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals.

Bristol-Myers Squibb shares dropped over 2% Monday to their lowest level since the beginning of the COVID-19 pandemic, while 2seventy bio shares sank more than 16% to their all-time low.