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The subcutaneous daratumumab-hyaluronidase (Darzalex Faspro) in combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant, the agency announced Tuesday.

Approval was based on results from the phase III PERSEUS trial, which evaluated 709 patients ages 70 and younger who were randomized to daratumumab-hyaluronidase plus VRd or the VRd triplet.

Daratumumab-hyaluronidase plus VRd led to a significant improvement in the primary endpoint of progression-free survival, reducing the risk of disease progression or death by 60% compared with VRd (HR 0.40, 95% CI 0.29-0.57, P<0.0001).

"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 Krishnan, MD, director of the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope in Duarte, California, in a from daratumumab-hyaluronidase drugmaker Johnson & Johnson.

"The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding [daratumumab-hyaluronidase to] VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation," Krishnan added.

PERSEUS results, which were presented at the American Society of Hematology annual meeting last year, also included an interim analysis that showed a trend toward improved overall survival in favor of daratumumab-hyaluronidase plus VRd.

The most common adverse reactions (≥20%) were peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash.

The FDA approved daratumumab-hyaluronidase injection for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in , and it is now approved for nine indications in multiple myeloma, including four for frontline treatment of newly diagnosed patients.

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