FDA Set To Prioritize Review Of Bristol-Myers Squibb Cancer Cell Therapy Critical To Celgene Merger

Off the back of its $74 billion acquisition of Celgene, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted its biologics license application (BLA) for its CAR-T treatment priority review. This means a decision will come as soon as August 17, 2020, which is four months earlier than it would have under the standard review process.

Similar to other CAR-T therapies, liso-cel involves taking immune cells and manipulating them so they target lymphoma cells expressing proteins consistent with blood cancer, like CD19. Currently, liso-cel is an investigational compound that is not approved for use in any country. Bristol-Myers acquired liso-cel through its procurement of Celgene, though the treatment was originally developed by the biotech firm, Juno Therapeutics which it acquired in 2018. Bristol-Myers currently has a number of CAR-T therapies as well as others that involve a similar technique using the T-cell receptor to target tumor cells.

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If on-time approval is secured, Bristol-Myers would be well ahead of its deadline set out in its agreement with Celgene, where the company was to pay $9 more per share as part of the buyout.

"There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients," said Stanley Frankel, the senior vice president of Cellular Therapy Development at Bristol-Myers Squibb. "Based on the TRANSCEND NHL 001 data, liso-cel has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed. This BLA acceptance and Priority Review designation is an important step as we work to improve treatment for these patients in need."

The BLA application was supported by data from the Phase 1 trial, where out of 256 patients therapy with liso-cel cleared all detectable traces of cancer in more than half of the patients (53%), and partially shrunk tumor volumes in another 20%.

If approved, liso-cel will join two other CAR-T treatments that have previously obtained FDA approval to treat types of lymphoma, which is Novartis' Kymriah and Gilead Sciences' Yescarta.