FDA Approves Darzalex Faspro for Multiple Myeloma

On Wednesday, August 7, 2024, the U.S. Food and Drug Administration (FDA) approved a new combination treatment for patients with newly diagnosed multiple myeloma (MM) who are candidates for an autologous stem cell transplant (ASCT). The approved regimen, known as Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), is set to become a new standard in the initial treatment and consolidation phases for these patients.

The approval stems from a phase 3 clinical trial that evaluated the efficacy and safety of the D-VRd regimen during the induction and consolidation periods in multiple myeloma patients eligible for ASCT. The trial's primary endpoint was progression-free survival, and the results indicated a significant improvement in this parameter, showing a hazard ratio of 0.40. Additionally, the trial highlighted that minimal residual disease (MRD) negativity rates were significantly higher with D-VRd compared to VRd alone, with rates of 57.5% versus 32.5%. Moreover, among patients who achieved a complete response or better, MRD negativity rates were 76.6% with D-VRd compared to 58.5% with VRd.

The study also reported the common adverse reactions associated with the D-VRd regimen. These included peripheral neuropathy, fatigue, edema, fever, upper respiratory infections, constipation, diarrhea, musculoskeletal pain, insomnia, and rash, all affecting 20% or more of the patients treated with D-VRd.

Dr. Amrita Y. Krishnan, from the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope in Duarte, California, emphasized the importance of this new treatment option. She noted that multiple myeloma presents a complex and varied clinical course, both among different patients and within the same patient over time. Consequently, there is a pressing need for innovative therapies that target different mechanisms and offer new combinations, providing patients with a variety of options from their initial diagnosis through the progression of their disease. Dr. Krishnan highlighted the compelling efficacy data supporting the D-VRd regimen, coupled with its established safety and tolerability profile, as evidence that this quadruplet therapy can enhance treatment responses and prolong remission in the context of ASCT.

The FDA granted the approval of Darzalex Faspro to Johnson & Johnson, marking a significant milestone in multiple myeloma treatment. This new regimen promises to deepen therapeutic responses and extend remission times for patients undergoing autologous stem cell transplantation, offering a new beacon of hope in the management of this challenging disease.