Johnson & Johnson (NYSE: JNJ) has announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for use as induction and consolidation therapy in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant (ASCT). This approval provides a new option for these patients, potentially enhancing their treatment outcomes.

This approval is based on results from the Phase 3 PERSEUS study, which compared the effectiveness of D-VRd with bortezomib, lenalidomide, and dexamethasone (VRd) for induction and consolidation in NDMM patients eligible for ASCT. After consolidation, patients received an investigational maintenance regimen involving DARZALEX FASPRO® either alone or combined with lenalidomide.

Dr. Amrita Y. Krishnan, Professor and Director of the Judy and Bernard Briskin Multiple Myeloma Center at City of Hope, highlighted the significance of this new therapy. The study showed that D-VRd resulted in a 60 percent lower risk of disease progression or death compared to VRd (HR [95% CI]: 0.40 [0.29, 0.57]; p-value < 0.0001). D-VRd also achieved higher rates of minimal residual disease (MRD) negativity and deeper overall responses.

Johnson & Johnson emphasized that this new indication for DARZALEX FASPRO®-based quadruplet therapy offers a substantial benefit by reducing disease progression during first-line treatment and improving initial responses for patients.

The safety profile of D-VRd is consistent with what is known for DARZALEX FASPRO® and VRd, with common adverse effects including peripheral neuropathy, fatigue, edema, fever, and various infections.

The PERSEUS study, sponsored by the European Myeloma Network, is an ongoing Phase 3 trial comparing D-VRd and VRd regimens. The study’s primary endpoint is progression-free survival (PFS), and secondary endpoints include overall complete response rates and MRD negativity. It involves patients from 14 countries across Europe and Australia.

Multiple myeloma is a type of blood cancer affecting plasma cells in the bone marrow, making it the second most common blood cancer worldwide. Despite advancements in treatment, it remains incurable, with more than 35,000 new cases expected in the U.S. in 2024. DARZALEX FASPRO® is a subcutaneous CD38-directed antibody approved for multiple indications in multiple myeloma and uses Halozyme’s ENHANZE® drug delivery technology.

 

Source: prnewswire.com

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