FDA Review of BLA for Liso-Cel in Relapsed/Refractory Large B-Cell Lymphoma Delayed by COVID-19

The review of the biologics license application (BLA) for the CAR T-cell product lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) following at least 2 previous therapies has been delayed, according to Bristol Myers Squibb, the manufacturer of the therapy.¹

The regulatory agency was not able to conduct an inspection of a third-party manufacturing facility based in Texas during the current review cycle because of travel restrictions put in place because of the coronavirus disease 2019 pandemic. In light of this, the FDA has deferred action on the application until this task can be completed. A new action date has not been announced, but the drug remains under review.

“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, stated 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.”

The initial action date set for the BLA was August 17, 2020. In May 2020, the FDA added 3 months to the review period for liso-cel to allow for the review of additional information provided by the pharmaceutical company.

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