FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients

Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) recently approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). This new treatment option at initial diagnosis aims to significantly improve patient outcomes.

The approval is based on data from the Phase 3 PERSEUS study. The study evaluated the effectiveness of DARZALEX FASPRO® combined with D-VRd for induction and consolidation therapy compared to the standard VRd regimen. Following consolidation, patients received either DARZALEX FASPRO® with lenalidomide or lenalidomide alone for maintenance.

“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 Dr. Amrita Y. Krishnan, Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center, City of Hope.

The PERSEUS study showed a 60% reduction in the risk of disease progression or death with D-VRd compared to VRd. The primary endpoint, progression-free survival (PFS), showed significant improvement. D-VRd also resulted in deeper responses post-consolidation, with minimal residual disease (MRD) negativity rates of 57.5% versus 32.5% for VRd.

“This latest indication for DARZALEX FASPRO-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment,” said Dr. Jordan Schecter, Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. “Today’s approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant eligible.”

The safety profile of D-VRd was consistent with known profiles for DARZALEX FASPRO® and VRd. Common adverse reactions included peripheral neuropathy, fatigue, edema, and upper respiratory infections.

The new approval offers hope for newly diagnosed multiple myeloma patients, providing a robust treatment option aimed at improving long-term outcomes.