Bristol Myers Squibb, a biopharmaceutical company based in Princeton, N.J., has recently been granted priority review by the U.S. Food and Drug Administration (FDA) for two applications related to the expanded approval of its CAR-T cell therapy, Breyanzi. These applications aim to extend the usage of Breyanzi for patients with specific types of lymphomas.
One of the applications focuses on using Breyanzi as a treatment for adults with relapsed or refractory follicular lymphoma, while the other targets relapsed or refractory mantle cell lymphoma following the utilization of a Bruton tyrosine kinase inhibitor.
The FDA’s priority review designation is reserved for medications that have the potential to bring significant improvements in treating severe diseases. This designation also accelerates the review period, ensuring faster access to potentially life-saving treatments.
For the follicular lymphoma indication, the FDA has set a target action date of May 23, 2024. Similarly, for the mantle cell lymphoma indication, the target action date is May 31.
In addition to the FDA’s review, Bristol Myers Squibb has also submitted an application to Japan’s Ministry of Health, Labour and Welfare, seeking expanded approval for Breyanzi in relapsed or refractory follicular lymphoma.
Bristol Myers Squibb reported that its worldwide revenue from Breyanzi reached $263 million during the first nine months of 2023. This impressive figure indicates a significant increase compared to the revenue generated during the same period last year.