The FDA granted a priority review to Bristol-Myers Squibb Company’s biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) to treat adult patients with relapsed or refractory large B-cell lymphoma.
Juno Therapeutics, a subsidiary of Bristol-Myers Squibb Company, submitted the BLA for liso-cel, it’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy, to treat patients who have undergone 2 prior therapies.
“There remains a critical need for additional therapies in large B-cell lymphoma, particularly for relapsed or refractory patients,” said Stanley Frankel, MD, senior vice president of cellular therapy development at Bristol-Myers Squibb, in a news release.
The BLA comes on the heels of the safety and efficacy results from the TRANSCEND NHL 001 trial, in which researchers evaluated liso-cel in 268 patients with relapsed or refractory large B-cell lymphoma.
The primary outcomes for this open-label, multicenter, phase I study were treatment-related adverse events, dose-limiting toxicities, and objective response rate, with secondary outcomes including complete response rate, duration of response, and progression-free survival.
The study, which is the largest of its kind to support CD19-directed CAR T-cells, was presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition. Liso-cel was previously granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations by the FDA before this Priority Review designation.
“Based on the TRANSCEND NHL 001 data, liso-cel has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed,” said Frankel in a news release. “This BLA acceptance and Priority Review designation is an important step as we work to improve treatment for these patients in need.”
The FDA set the Prescription Drug User Fee Act (PDUFA) goal date for liso-cel at August 17, 2020.
Large B-cell lymphoma is an aggressive form of non-Hodgkin lymphoma (NHL). It is the most common of the large B-cell lymphomas, accounting for approximately 60% of cases. About a third of patients with diffuse large B-cell lymphoma relapse after first-line treatment.
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) for Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma [news release]. Princeton, New Jersey. Published February 13, 2020. https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol. Accessed February 13, 2020.