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Bristol Myers Squibb CAR-T Cell Therapy Breyanzi FDA Priority Review

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Andrew R. Michaud

• November 09, 2023

Bristol Myers Squibb has received priority review from the U.S. Food and Drug Administration (FDA) for its application to expand the approval of its CAR-T cell therapy, Breyanzi. The application focuses on certain patients with lymphocyte cancers.

Specifically, the New York biopharmaceutical company's application seeks approval for Breyanzi in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously received a Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.

The FDA grants priority review status to medications that have the potential to significantly improve the treatment of serious diseases. This designation helps to expedite the review process.

Bristol Myers has announced that the FDA has set a target action date of March 14, 2024, for the application. Currently, there is no established standard of care or many treatment options available for the patient population covered by this proposed indication.

In the first nine months of 2023, Bristol Myers reported global Breyanzi revenue of $263 million, which is more than double the revenue from the previous year.