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Autologous, BCMA, CAR-T, CD19

Breyanzi’s EU Approval Continues to Face Delays; Could Yescarta Receive an EC Approval for R/R FL by November 2021? No Mention of Cilta-cel in August’s CHMP Agenda

Here is a brief preview of this blast: On Monday, August 16, the CHMP agenda for August was released. Of note, BMS has requested an additional clock-stop extension for Breyanzi (CD19 CAR-T), while Yescarta (Gilead’s CD19 CAR-T) has been listed under Type II variations to include ≥4L r/r FL as a new indication. Furthermore, no updates were observed for cilta-cel (JNJ’s / Legend’s BCMA CAR-T). Below, Celltelligence provides likely EU approval timelines for Breyanzi, Yescarta, and cilta-cel.

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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.