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

Legend Biotech Corporation 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.