(CercleFinance.com) – Bristol Myers Squibb indicates that health authorities have agreed to examine three regulatory applications relating to Breyanzi (lisocabtagene maraleucel): two applications have been accepted by the Food and Drug Administration (FDA) of the United States , the third was by the Japanese Ministry of Health, Labor and Welfare (MHLW).
More concretely, in the United States, the FDA has agreed to study two additional biological product license applications (sBLA) for Breyanzi, thus making it possible to extend the indication of this treatment to adult patients suffering from follicular lymphoma. relapsed or refractory as well as patients affected by relapsed or refractory mantle cell lymphoma.
The FDA has also agreed to study these requests as part of a priority review and its response is expected in the last half of May.
In Japan, the MHLW of Japan has also agreed to review the supplemental new drug application (sNDA) for Breyanzi as a treatment for relapsed or refractory follicular lymphoma.
“These filing acceptances in the United States and Japan support our commitment to providing our best-in-class cell therapy treatments to as many eligible patients as possible,” commented Anne Kerber, Senior Vice President and Head of Clinical Development, hematology, oncology, cell therapy at Bristol Myers Squibb.
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