FDA Delays Decision on Liso-Cel for Large B-Cell Lymphoma

The FDA has deferred its decision on the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B-cell lymphoma. The agency did not set a new time for the review, but noted that it was not complete by the Prescription Drug User Fee Act action date of November 16, 2020.

The delay is related to travel restrictions due to the COVID-19 pandemic that prevented the agency from inspecting a third-party manufacturing facility in Texas during the current review cycle of liso-cel. The application will remain under review until the FDA can complete the , which is likely to be delayed into 2021.

“Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel,” said Samit Hirawat, MD, the company’s Executive Vice President and Chief Medical Officer of Global Drug Development. “We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need.”

The BLA was submitted based on data from the TRANSCEND NHL 001 trial evaluating liso-cel in 268 patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, high-grade lymphoma, primary mediastinal B-cell lymphoma, and grade 3b follicular lymphoma.