Bristol Myers scores FDA priority review in high-stakes expansion bid for CAR-T drug Breyanzi

Just over a year after Bristol Myers Squibb gained approval for CAR-T therapy Breyanzi as a third-line treatment for relapsed or refractory large B-cell lymphoma (LBCL), the company has hit a key milestone in expanding its use to the second line.

Thursday, the FDA accepted the company’s supplemental biologics license application (BLA) for Breyanzi after the failure of first-line treatment in the disease type. The regulator has assigned it priority review with a prescription drug user fee act (PDUFA) goal date of June 24.

The priority review is based on results of a phase 3 trial which showed that Breyanzi outperformed standard of care in second-line LBCL patients, helping more of them clear tumors or stave off progression of the disease. It was the first time in the indication that any treatment proved its worth over combinations of Roche’s Rituxan and high-dose chemotherapy, followed by stem-cell transplant.

Investigators presented the trial results at the American Society of Hematology meeting two months ago.

“This acceptance from the FDA brings us one step closer to delivering a practice-changing treatment,” Ann Kerber, BMS’ senior vice president for cell therapy and development, said in a release. “And (it) underscores the advancements we’re making in cell therapy research.”

Along with multiple myeloma treatment Abecma, which also won FDA approval last year, BMS has two CAR-T treatments for blood cancers that have shown promise.

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While Breyanzi generated $87 million in sales after its approval last year, Abecma pulled in $164 million, treating a cancer that has a larger patient population. Still, BMS has big expectations for Breyanzi, and the potential second-line nod is a big part of the picture for the drug in the long term.

“Breyanzi and Abecma continue to see significant demand while we remain focused on broadening supply and expanding indications over time,” BMS CEO Giovanni Caforio said two weeks ago during the company’s quarterly earnings call. “We continue to see Breyanzi as one of the key growth drivers for the company with over $3 billion in non-risk-adjusted revenue potential.”

The progression of the CAR-T therapies is key as BMS faces loss of exclusivity next month for cash cow Revlimid, which was gained in the company’s acquisition of Celgene and generated $12.8 billion in sales last year.

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Beefing up supply for both treatments is critical for BMS, chief commercialization officer Chris Boerner, Ph.D., said during the earnings call.

“As it relates to Breyanzi, the big focus there is on vector supply,” Boerner said. “We expect to be in position to support demand as we get later into this year and certainly by the time we would have label expansions for that product.”