J&J says ODAC recommends Carvykti for earlier treatment of myeloma

Johnson & Johnson announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee, or ODAC, recommends 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 who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of Carvykti, 11 to 0, finding the risk-benefit assessment of Carvykti 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 Prescription Drug User Fee Act, or PDUFA, date of April 5, J&J noted. “We are pleased with the advisory committee’s support for Carvykti in earlier lines of treatment based on the CARTITUDE-4 data. As a physician and researcher committed to advancing patient care, the potential of Carvykti in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.