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Autologous, BCMA, CAR-T, CD19

March 22, 2021

Cilta-cel’s MAA Not Submitted; No Regulatory Updates for Liso-cel and Ide-cel; CHMP March Agenda

Here is a brief preview of this blast: On Monday, March 22, the CHMP agenda for March was released. Of note, JNJ / Legend’s BCMA CAR-T cilta-cel does not appear in either the agenda or the updated list of drugs under evaluation, suggesting that cilta-cel’s MAA has not yet been submitted to the EMA. Furthermore, no regulatory updates for BMS’s liso-cel (CD19 CAR-T) or ide-cel (BCMA CAR-T) were provided. Below, Celltelligence provides an update for cilta-cel’s likely EU approval timeline.

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The Celltelligence Team

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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.