US FDA Nods Johnson & Johnson's Darzalex Faspro for Patients with NDMM

Johnson & Johnson stated that the FDA has given approval for Darzalex Faspro to be used in combination with D-VRd for induction and consolidation in eligible NDMM patients for ASCT. Patients will be able to get this Darzalex Faspro-containing quadruplet therapy at the start of their diagnosis, giving them a new treatment option that could greatly enhance results.

The phase 3 PERSEUS study provided data backing the approval of Darzalex Faspro in a regimen that included D-VRd induction and consolidation therapy compared to VRd in NDMM patients eligible for ASCT. After the merger, patients were given an experimental maintenance treatment plan consisting of either Darzalex Faspro with lenalidomide or just lenalidomide.

“Multiple myeloma has a highly varied clinical course among patients and in each individual patient, and there is a continued need for innovation and therapies that employ different targets and combinations to provide patients with treatment options at diagnosis and throughout the course of their disease,” said Amrita Y. Krishnan, M.D., Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope. “The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation.”