Benzinga | May 27, 2021 08:26AM EDT

Legend Biotech-Janssen's Multiple Myeloma Cell Therapy Under Review In US

* Legend Biotech Corporation (NASDAQ:LEGN) has announced that the FDA accepted for priority review the marketing application submitted by Janssen Biotech Inc for ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma.

* Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy.

* The agency's target action date has been set for November 29.

* The submission is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study, which evaluated the efficacy and safety of cilta-cel.

* Updated longer-term follow-up data will be featured at the upcoming American Society of Clinical Oncology Annual Meeting next month.

* Price Action: LEGN stock closed at $37.54 on Wednesday.