FDA further delays decision on lisocabtagene maraleucel CAR-T for large B-cell lymphoma
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The FDA for a second time delayed a decision on a biologics license application for lisocabtagene maraleucel, a chimeric antigen receptor T-cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma.
Lisocabtagene maraleucel (Bristol Myers Squibb) — commonly called liso-cel — is an autologous anti-CD19 CAR T-cell therapy that targets the CD19 antigen expressed on the surface of cancer cells.
The FDA informed Bristol Myers Squibb that it could not complete review of the application by the Nov. 16 action date because of the agency’s inability to inspect a third-party manufacturing facility in Texas.
The FDA could not conduct the site visit due to COVID-19 travel restrictions and will delay a decision until the inspection can be conducted, according to a Bristol Myers Squibb-issued press release. The agency did not provide a new action date.
“Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the [biologics license application] for liso-cel,” Samit Hirawat, MD, executive vice president and chief medical officer for global drug development at Bristol Myers Squibb, said in the release.
“We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need,” he added.
The FDA granted priority review for liso-cel in February and set an action date of Aug. 17. The agency subsequently requested additional data from the manufacturer and moved the action date to Nov. 16.
The FDA approved three other CAR T-cell therapies between August 2017 and August of this year: tisagenleleucel (Kymriah, Novartis) for treatment of certain patients with diffuse large B-cell lymphoma or B-cell acute lymphoblastic leukemia; axicabtagene ciloleucel (Yescarta, Kite Pharma/Gilead) for treatment of adults with relapsed or refractory large B-cell lymphoma; and brexucabtagene autoleucel (Tecartus, Kite Pharma/Gilead) for treatment of adults with relapsed or refractory mantle cell lymphoma.
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