JNJ / Legend Receive Priority Review for Cilta-cel in MM; Approval Before Thanksgiving?
On Wednesday, May 26, Legend announced (press release) that the FDA has granted cilta-cel (BCMA CAR-T) Priority Review in r/r MM, with a projected PDUFA date around November 29, 2021. Furthermore, management confirmed that updated results from the Ph1b/2 CARTITUDE-1 trial will be presented at ASCO 2021. Below, Celltelligence provides additional thoughts on cilta-cel’s anticipated US approval and its potential best-in-class efficacy profile, while discussing JNJ’s / Legend’s possible US ATC onboarding strategy.
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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.
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