Bristol-Myers finds FDA receptive to speedy review of key cell therapy

Bristol-Myers finds FDA receptive to speedy review of key cell therapy

Credit: Courtesy of Bristol-Myers Squibb

Dive Brief:

  • Former shareholders in Celgene, bought by Bristol-Myers Squibb last year for $74 billion, can rest easier knowing the Food and Drug Administration will quickly review a cancer cell therapy that was one of three experimental drugs critical to the merger. 
  • On Thursday, Bristol-Myers announced the FDA granted the CAR-T treatment, called liso-cel, priority review, setting up a decision by Aug. 17, 2020. An on-time approval, if secured, would be well ahead of the year-end deadline set out by Bristol-Myers in an agreement to pay $9 more per Celgene share as part of its takeover offer.
  • Liso-cel, which treats a type of lymphoma, was originally developed by biotech Juno Therapeutics before its acquisition by Celgene in 2018. An approval would make it the third CAR-T treatment to reach market after Gilead’s Yescarta and Novartis’ Kymriah. 

Dive Insight:

In buying Celgene, Bristol-Myers identified five drugs that it thought could help add $15 billion in revenue to the combined company, three of which it tied to a payout agreement known as a contingent value right, or CVR.

Should liso-cel, an experimental multiple sclerosis drug called ozanimod and a second cell therapy dubbed ide-cel all win U.S. approval by certain specified dates, Bristol-Myers will owe holders of the CVR $9 per share.

Securing priority review for liso-cel makes accomplishing that easier by shortening the agency’s review of the drug from the standard 10 months to six.

Although Bristol-Myers can point to positive data showing liso-cel to be effective at spurring cancer remissions, getting the FDA to sign off on a priority review wasn’t guaranteed. Yescarta and Kymriah, both CAR-T treatments aimed at the same tumor protein, are already cleared for use in the same kind of lymphoma liso-cel treats. 

Bristol-Myers is liso-cel’s third corporate owner after Celgene and Juno. All three have successively touted liso-cel as potentially best in its class, noting in particular the lower rates of neurotoxicty and cytokine release syndrome observed in trials. 

But should liso-cel win an FDA OK in lymphoma this August, it will arrive on market some 34 months after Yescarta and 27 months after Kymriah received their respective approvals for the disease. An August 2020 decision would also be well after what executives at first Juno and then Celgene initially promised.

Sales of Yescarta and Kymriah, meanwhile, have remained modest, hampered by commercial and manufacturing challenges that could make Bristol-Myers’ hopes of billion-dollar sales for liso-cel a reach.

And liso-cel’s purported safety edge might not be as clear-cut as trial data to date shows. A study presented last year at the American Society of Hematology’s annual meeting showed real-world rates of CRS and neurotoxicity to be much lower for Kymriah than in the study that supported its lymphoma approval. 

Bristol-Myers cell therapy prospects look better with ide-cel, which could become the first CAR-T treatment approved to treat multiple myeloma. (Competitors, though, threaten.) And ozanimod could give Bristol-Myers its first drug for multiple sclerosis, a lucrative, albeit crowded, market. 

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Originally posted on biopharmadive.com


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