SOMERSET, N.J.– Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended Janssen Pharmaceutica NV’s marketing authorization of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies. CAR-T therapy is a highly personalized technology where a person’s own T-cells are engineered to target and kill cancer cells in a single infusion.
Data from the ongoing pivotal CARTITUDE-1 study supported the positive CHMP opinion. Two-year follow-up results were presented at the American Society of Hematology (ASH) 2021 Annual Meeting (Abstract #549).
“The positive CHMP opinion reinforces the potential of cilta-cel for patients with multiple myeloma around the world,” said Ying Huang, Ph.D., Chief Executive Officer and Chief Financial Officer of Legend Biotech. “We look forward to the EMA to the potential of European Commission approval in the future and continued progress in the development of cilta-cel.”
Multiple myeloma is an incurable blood cancer affecting a type of white blood cell called plasma cells, which are found in the bone marrow.3 The majority of patients relapse after undergoing initial treatment and face poor prognoses after treatment with three major drug classes, including an immunomodulatory agent, a proteasome inhibitor and anti-CD38 monoclonal antibody.
