Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA has set a Prescription Drug User Fee Act goal date of Aug. 17.
In last week’s issue of The Cancer Letter, Jacquelyn Cobb, associate editor, wrote a story about the then-promising legislative package that was passed by the U.S. House of Representatives Jan. 22. At the time, the package was expected to pass in the Senate, provide funding for the federal government through fiscal year 2026, and prevent a government shutdown that looms Jan. 30.
