Legend Biotech says Carvykti approved by EC for second-line multiple myeloma

Legend Biotech (LEGN) announced that the European Commission, or EC, has granted approval of Carvykti for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, have demonstrated disease progression on the last therapy and are refractory to lenalidomide. The Type-II variation application was submitted to the European Medicines Agency by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, a Johnson & Johnson (JNJ) company, Legend Biotech’s collaborator for the development and commercialization of Carvykti. “The European Commission’s approval of Carvykti has the potential to transform the treatment paradigm for patients battling multiple myeloma by bringing our novel therapy to them earlier in the course of this incurable disease,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “This approval is a testament to our innovative science and galvanizes our efforts to provide new options that will improve outcomes for patients and give hope to them and their families.”