Expanded Indications for Liso-Cel Under Review in US, Japan

Lisocabtagene maraleucel (liso-cel), a chimeric antigen receptor T-cell therapy, received two regulatory acceptances from the US Food and Drug Administration (FDA) and one from the Ministry of Health, Labour and Welfare (MHLW) of Japan, according to a release from Bristol Myers Squibb.

The FDA accepted two additional supplemental Biologics License Applications that expand indications for liso-cel to include patients with relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma (MCL) after a previous Bruton’s tyrosine kinase inhibitor. Both applications were granted Priority Review and assigned action dates in May 2024.

Japan’s MHLW accepted a supplemental New Drug Application for liso-cel in the treatment of relapsed or refractory follicular lymphoma.

“Patients living with follicular lymphoma and mantle cell lymphoma often experience cycles of remission and relapse with multiple lines of treatment, and we are committed to delivering innovative treatment solutions to this population,” said Anne Kerber, MD, the senior vice president and head of the Late Clinical Development, Hematology, Oncology, Cell Therapy division at Bristol Myers Squibb.

The applications are based on the TRANSCEND FL and TRANSCEND NHL 001 studies for follicular lymphoma and MCL, respectively. Both studies reported promising rates of complete responses with liso-cel with no new safety signals identified.