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The FDA has added 3 months to the review period for a biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma (LBCL) after at least 2 prior therapies. The extension will allow the agency to review additional data provided by Bristol Myers Squibb, the manufacturer of the anti-CD19 CAR T-cell therapy.

The FDA has granted a priority review designation to a supplemental new drug application (sNDA) for selinexor (Xpovio) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, who have received ≥2 prior therapies.

Now that the CD19-targeted CAR T-cell therapies axicabtagene ciloleucel (axi-cel; Yescarta) and tisagenlecleucel (Kymriah) have shown durable responses in the relapsed/refractory settings of non-Hodgkin lymphoma, researchers are hopeful that earlier exposure may heighten the curative potential of the modality, explained Mazyar Shadman, MD, MPH.