Feb 13, 2020: U.S.FDA accepted for the Priority Review its Biologics License Application (BLA) for BMS’s lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.
A Prescription Drug User Fee Act (PDUFA) set by FDA as goal date of August 17, 2020.
The BLA, submitted by the Juno Therapeutics, a completely owned subsidiary of BMS, is based on the safety and efficient results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with the R/R large B-cell lymphoma, that include diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.
TRANSCEND NHL 001 is the major study of CD19-directed CAR T cells in order to support a BLA to date and was the new subject of an oral presentation at the 61st American Society of Hematology Annual Meeting and Exposition. A priority review classification, according to the FDA, would concentrate overall attention and resources on reviewing drug applications that, if approved, will substantially improve the
safety or efficacy of treatment, diagnosis, or prevention of severe conditions compared to standard applications. Previously, Liso cel was granted FDA Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations for active R / R major B-cell non Hodgkin lymphoma, like DLBCL, not otherwise defined (de novo or transformed from indolent lymphoma), PMBCL or Grade 3B FL, and Priority Medicines (PRIME) by the European Medicines Agency for R / R DLBCL.
https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol
