Legend Biotech notes ODAC recommends Carvykti for earlier treatment of myeloma

Legend Biotech (LEGN) announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee, or ODAC, recommended Carvykti for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide. The positive recommendation follows the committee’s evaluation of efficacy and safety data from the Phase 3 CARTITUDE-4 study. The committee voted unanimously in favor of Carvykti, 11 to 0, finding the risk-benefit assessment of cilta-cel for the proposed indication as favorable. A supplemental Biologics License Application, or sBLA, supported by the CARTITUDE-4 study is currently under review by the FDA with a target Prescription Drug User Fee Act, or PDUFA, date of April 5, Legend noted. “The advisory committee’s positive recommendation for Carvykti brings us one step closer to helping more patients fighting relapsed and refractory multiple myeloma. We are committed to improving the lives of patients with multiple myeloma, and we’re excited by the prospect of bringing our innovative therapy to patients earlier in the course of their disease,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, a Johnson & Johnson (JNJ) company, to develop and commercialize cilta-cel.