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FDA Sets Review Dates for New Indications for Breyanzi


Bristol Myers Squibb is seeking approval of Breyanzi, a CD19-directed CAR T-cell therapy, to treat patients with follicular lymphoma and mantle cell lymphoma.

The FDA has accepted Bristol Myers Squibb’s two supplemental biologics license applications (sBLA) for Breyanzi (lisocabtagene maraleucel) to expand into new indications. The FDA has granted both applications priority review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 23, 2024, for Breyanzi in relapsed or refractory follicular lymphoma (FL) and May 31, 2024, for Breyanzi in relapsed or refractory mantle cell lymphoma (MCL).

Follicular lymphoma is the second most common, slow-growing form of NHL, accounting for 20% to 30% of all non-Hodgkin lymphoma cases. Most patients over the age of 50 years. It develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. In relapsed or refractory FL, the application is based on results from the TRANSCEND FL study. In the study, Breyanzi demonstrated high rates of complete responses.

Mantle cell lymphoma is an aggressive, rare form of non-Hodgkin lymphoma and represents about 3% cases. ginates from cells in the “mantle zone” of the lymph node. MCL occurs more frequently in older adults with an average age at diagnosis in the mid-60s. In MCL, relapse after initial treatment is common. In relapsed or refractory MCL, the application for Breyanzi is based on results from the MCL cohort of the TRANSCEND NHL 001 study, in which Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients, with the majority of patients achieving a complete response.

Results from both trials were presented at the 2023 International Conference on Malignant Lymphoma (ICML) in June 2023 and at the American Society of Hematology (ASH) Annual Meeting in December 2023.

Breyanzi is a CD19-directed CAR T cell therapy. It is already approved to treat adult patients with large B-cell lymphoma. It is also approved to treat patients with follicular lymphoma who have refractory disease or who have relapsed within 12 months of first-line chemoimmunotherapy.

The therapy is derived from a patient’s own T cells that have been engineered to target CD19 B cells. Drugs.com shows a price for Breyanzi of $513,323.

A sBLA for Breyanzi to treat adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma is also currently under priority review with an assigned target action date of March 14, 2024.

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