Will Kymriah Receive a CHMP Positive Opinion in R/R FL This Week? Carvykti’s CHMP Opinion Likely to Occur by February 2022; Tecartus and Breyanzi Continue to Experience Delays; December’s CHMP Agenda

On Monday, December 13, the CHMP agenda for December was released. Of note, Kymriah’s (Novartis’s CD19 CAR-T) Type II variation for r/r FL is listed as ‘For Adoption’, while Carvykti (JNJ / Legend’s BCMA CAR-T; cilta-cel) is displayed under the ‘List of outstanding issues (LoOI)’ section. Moreover, Tecartus (Gilead’s / Kite’s CD19 CAR-T) and Breyanzi (BMS’s CD19 CAR-T) were absent from December’s CHMP agenda. Below, Celltelligence provides insights on potential EU approval timelines for Kymriah and Carvykti, while discussing possible causes for Tecartus’s and Breyanzi’s regulatory delays.

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