Bristol Myers Squibb reports that health authorities have agreed to review three regulatory applications for Breyanzi (lisocabtagene maraleucel): two applications have been accepted by the US Food and Drug Administration (FDA), the third by the Japanese Ministry of Health, Labor and Welfare (MHLW).

More concretely, in the United States, the FDA has agreed to consider two additional Biologics License Applications (sBLAs) for Breyanzi, extending the indication of this treatment to adult patients with relapsed or refractory follicular lymphoma, as well as patients with relapsed or refractory mantle cell lymphoma.

The FDA has agreed to review these applications on a priority basis, and a response is expected in the last half of May.

In Japan, Japan's MHLW has also agreed to review the supplementary new drug application (sNDA) for Breyanzi as a treatment for relapsed or refractory follicular lymphoma.

' These filing acceptances in the U.S. and Japan support our commitment to deliver our best cell therapy treatments to as many eligible patients as possible', commented in essence Anne Kerber, Senior Vice President and Head of Clinical Development, Hematology, Oncology, Cell Therapy at Bristol Myers Squibb.


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