LGND - FDA grants J&J multiple myeloma treatment cilta-cel priority review
The FDA has accepted with priority review the BLA for Johnson & Johnson (JNJ) Janssen unit's ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma.The PDUFA date is November 29, 2021.Janssen began a rolling submission of the CAR-T therapy in December.J&J is partnered on cilta-cel with Legend Biotech (LGND).The European Medicines Agency accepted a marketing application for cilta-cel last week.J&J shares are up 0.1% to $169.16 and Legend shares are unchanged at $114.90 in after-hours trading.
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FDA grants J&J multiple myeloma treatment cilta-cel priority review