The FDA granted a priority review for biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), to treat adults with relapsed or refractory large B-cell lymphoma who had at least 2 prior therapies, according to a press release from Bristol-Myers Squibb, the manufacturer of the chimeric antigen receptor (CAR) T-cell therapy.
“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, Cellular Therapy Development, Bristol-Myers Squibb, in the release.
The Prescription Drug User Fee Act (PDUFA) date – when the FDA must decide whether or not to approve the agent—was set for Aug. 17, 2020.
The priority review was based on findings from the TRANSCEND NHL 001 trial, which included 268 patients with relapsed/refractory large B-cell lymphoma and Grade 3B follicular lymphoma, which was presented this December at the 61st American Society of Hematology Meeting and Exposition.
“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. This BLA acceptance and Priority Review designation is an important step as we work to improve treatment for these patients in need,” Frankel said.