The FDA will delay review of lisocabtagene maraleucel, an investigational CAR-T therapy under review for patients with B-cell lymphoma, according to the agent’s manufacturer. 

The FDA previously set a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2020, but was unable to complete an inspection of a third-party manufacturing facility in Texas during “due to travel restrictions related to the COVID-19 pandemic,” leading to a delay in the FDA’s decision. 

The Biologics License Application (BLA) lisocabtagene maraleucel is seeking an indication for adult patients with relapsed or refractory large B-cell lymphoma, who have received at least two prior therapies. 

The BLA was based on results from the TRANSCEND NHL 001, which assessed  lisocabtagene maraleucel in 268 patients with diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma or grade 3B follicular lymphoma.

“Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel,” Samit Hirawat, MD, executive vice president and chief medical officer of global drug development at  Bristol Myers Squibb, said in a press release. “We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need.”

This is the second time the FDA has delayed approval for liso-cel. In May 2020, the manufacturer announced that the Agency had pushed the original PDUFA date back 3 months to November 16, 2020. At that time, the manufacturer explained that the delay was triggered after they “submitted additional information to the FDA, which was deemed to constitute a major amendment to the application and will require additional time for FDA review.”