U.S. FDA Accepts For Priority Review Bristol Myers Squibb's Application For Breyanzi Fior Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma
Portfolio Pulse from Benzinga Newsdesk
The U.S. FDA has accepted for priority review Bristol Myers Squibb's application for Breyanzi for relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The application is based on results from the TRANSCEND CLL 004 trial, which showed clinical benefit with a CAR T cell therapy in heavily pre-treated patients. The FDA has assigned a target action date of March 14, 2024. If approved, Breyanzi would be the first and only CAR T cell therapy available for this patient population.
November 09, 2023 | 3:14 pm
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The FDA's acceptance for priority review of Bristol Myers Squibb's application for Breyanzi could potentially lead to the drug being the first and only CAR T cell therapy available for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The FDA's acceptance for priority review indicates the potential significance of Breyanzi in treating patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. If approved, this could potentially boost Bristol Myers Squibb's market position and revenues, hence the positive score.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100