Summary of PRAC recommendation for Carvykti (ciltabtagene autoleucel)

Having considered the available evidence in EudraVigilance, including the cumulative review submitted by the Marketing Authorisation Holders (MAHs), the PRAC has agreed that the MAH of Carvykti (Janssen-Cilag International NV) should submit a variation within 2 months from the publication of the PRAC recommendation to amend product information as described below (new text underlined).

PRAC recommendations on signals adopted at the 2-5 June 2025 PRAC meeting