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Bristol Myers faces FDA delay on cancer cell therapy decision

Dive Brief:

  • The Food and Drug Administration plans to hold an advisory panel review of Bristol Myers Squibb and 2seventy bio’s application for an expanded approval of their multiple myeloma cancer therapy Abecma, the partner companies said Monday.
  • As a result, the FDA won’t decide on approval of the therapy by its originally scheduled deadline of Dec. 16. The agency has not set a date for the advisory committee meeting, which will review survival data from the companies’ study of Abecma earlier in the treatment of multiple myeloma. 
  • Shares in Bristol Myers fell by 2% Monday, while 2seventy stock dived by more than 15% on the news. The companies are counting on an expanded approval of Abecma to help boost sales of the so-called CAR-T drug. 

Dive Insight:

Last month, Bristol Myers delivered unwanted news, telling investors that sales of new drugs it’s counting on this decade will grow more slowly than expected. 

One of the chief culprits for that guidance shift was Abecma, sales of which dropped by 13% year over year during the third quarter. In an earnings call, Bristol Myers attributed that decline to increased competition from drugs like Johnson & Johnson and Legend Biotech’s rival myeloma therapy Carvykti, as well as to “manufacturing maintenance” being done to solve earlier production challenges. 

An expanded approval, allowing Abecma to be used earlier, has been pegged by analysts and the company as an important opportunity. Results from a clinical trial called KarMMA-3 showed that Abecma could hold multiple myeloma in check for longer than standard drug regimens among people who are “triple class-exposed,” or have been treated by three different types of medicines. 

“We knew this was going to be a highly competitive market, putting pressure on growth,” said Adam Lenkowsky, Bristol Myers’ chief commercialization officer on an Oct. 26 conference call. “Clearly, a KarMMA-3 approval would move Abecma into earlier lines of treatment and be a catalyst to return Abecma to growth by opening up a significant larger patient pool.”

Those plans are now delayed, however. Bristol Myers said it anticipates the planned advisory committee meeting to review patient survival results from that study. Data are set to be presented at the American Society of Hematology’s annual conference early next month. 

Earlier use of Abecma is also under review by regulators in Japan, the European Union and Switzerland. 

J&J, meanwhile, reported in October that sales of Carvykti grew to $152 million in the third quarter, compared to $55 million the year before. 


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