FDA delays decision on lisocabtagene maraleucel for adult patients with large B-cell lymphoma

The U.S. Food and Drug Administration (FDA) has announced that it will not meet the Prescription Drug User Fee Act (PDUFA) action date of November 16, 2020, for its review of the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel). Liso-cel is under review for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) following ≥ 2 prior therapies.

The BLA for liso-cel, a CD19-directed chimeric antigen receptor (CAR) T-cell product, was supported by the safety and efficacy data from the TRANSCEND NHL 001 trial. The ongoing phase I study is investigating liso-cel across a broad cohort of patients with relapsed/refractory LBCL, including diffuse large B-cell lymphoma, high-grade lymphoma, primary mediastinal B-cell lymphoma, and Grade 3b follicular lymphoma. The TRANSCEND NHL 001 study is the most extensive to support a BLA for CD19-directed CAR T-cell therapy. The full study design and key safety and efficacy results were presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition; read more here.

The FDA’s deferral decision follows an incomplete inspection of a third-party manufacturing facility. Travel restrictions, as a result of the COVID-19 pandemic, prevented the site visit and the FDA have not yet announced a new PDUFA action date.