Legend Biotech gets CHMP recommendation for expansion of Carvykti label

Legend Biotech (LEGN) announced the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended expansion of the Carvykti label to include adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. The Type II variation application was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech (JNJ), Legend Biotech’s collaborator for the development and commercialization of Carvykti. The positive opinion from the CHMP will now be reviewed by the European Commission which renders the final decision on approval.