FDA extends PDUFA date for cilta-cel

The US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target date for ciltacabtagene autoleucel (cilta-cel) to February 28, 2022.

Cilta-cel is a BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy being investigated for the treatment of adults with relapsed and/or refractory multiple myeloma. The Biologics License Application (BLA) was submitted by Janssen Biotech, a unit of US healthcare giant Johnson & Johnson (NYSE: JNJ), and is partnered with Legend Biotech (Nasdaq: LEGN), whose shares were down 10.8% at $47.01 before the opening bell this morning.

In December 2020, Janssen announced the initiation of a rolling submission of its BLA to the FDA for cilta-cel, which was accepted under Priority Review in May 2021.