The Food and Drug Administration (FDA) has approved the combination of daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) with bortezomib, lenalidomide, and dexamethasone for the induction and consolidation treatment of newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant (ASCT).
Image Source: Vinoth Khandelwal
This approval was based on the results of the PERSEUS trial (NCT03710603), an open-label, randomized, active-controlled study. The application received priority review status, utilizing the Assessment Aid to streamline the FDA’s evaluation process. The expedited review highlights the serious nature of multiple myeloma and the potential of this combination therapy to meet an unmet medical need.
Darzalex Faspro combines daratumumab, a monoclonal antibody targeting CD38 on myeloma cells, with hyaluronidase-fihj, an enzyme facilitating subcutaneous administration. This formulation allows for a more convenient and less invasive delivery compared to intravenous infusions, enhancing patient comfort and compliance.
The PERSEUS trial enrolled 709 patients, all aged 70 years or younger, with newly diagnosed multiple myeloma eligible for ASCT. Participants were randomized into two groups: 355 received Darzalex Faspro with bortezomib, lenalidomide, and dexamethasone (VRd), while 354 received VRd alone.
The primary efficacy outcome was progression-free survival (PFS), assessed by an independent review committee using the International Myeloma Working Group (IMWG) response criteria. The results showed a significant improvement in PFS for the Darzalex Faspro-VRd group compared to the VRd group. Notably, the median PFS had not been reached in either group, but treatment with Darzalex Faspro-VRd reduced the risk of disease progression or death by 60% (HR [95% CI]: 0.40 [0.29, 0.57]; p < 0.0001).
The FDA’s approval of Darzalex Faspro in combination with VRd for newly diagnosed multiple myeloma patients eligible for ASCT represents a significant advancement in treatment options, promising improved progression-free survival and a manageable safety profile. This combination therapy offers a new hope for patients, providing an effective and convenient option to combat this challenging disease.
Dr. Vinoth Khandelwal, Ph.D.
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