FDA Approves Johnson & Johnson’s Darzalex Faspro in Combination with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

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The FDA has approved Johnson & Johnson’s (J&J) Darzalex Faspro 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). According to the company, the new therapy can be administered right after diagnosis and could potentially lead to significantly improved outcomes for NDMM patients. The approval was based on positive results from the Phase III PERSEUS study, which compared D-VRd induction and consolidation therapy to the traditional VRd regimen in transplant-eligible NDMM patients.¹

"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 Y. Krishnan, MD, professor, director, Judy and Bernard Briskin Multiple Myeloma Center, City of Hope, in a press release. "The efficacy data supporting this new quadruplet regimen, combined with its established safety and tolerability profile, provide compelling evidence that adding D-VRd upon initial diagnosis as compared to VRd can deepen responses and prolong remissions in the context of autologous stem cell transplantation."

The ongoing, randomized, open-label PERSEUS study was started in collaboration with the European Myeloma Network as a sponsor. After consolidation therapy, patients received an investigational treatment regimen for maintenance that included Darzalex Faspro in combination with either lenalidomide or lenalidomide alone. The median age of participants in the study was 61 years in the D-VRd arm and 59 years in the VRd arm. Overall, the study included adults from 31-70 years of age. The primary endpoint of the study is progression-free survival (PFS), with secondary endpoints that include complete response (CR) or better and minimal residual disease and overall MRD-negativity in patients achieving a CR or better.

In the study, the safety profile of D-VRd was reported to be consistent with the known safety profiles of Darzalex Faspro. Common adverse events (AEs) included peripheral neuropathy, fatigue, edema, pyrexia, upper respiratory infection, constipation, diarrhea, musculoskeletal pain, insomnia, and rash. More severe AEs included hypoxia, dyspnea, hypertension, tachycardia, and ocular AEs, such as choroidal effusion, acute myopia, and acute angle closure glaucoma.

J&J warns that patients treated with Darzalex Faspro may experience systemic administration-related reactions, including severe or life-threatening reactions, and local injection-site reactions can occur, while fatal reactions have also been reported. Additionally, J&J recommends pre-medicating patients with histamine-1 receptor antagonist, acetaminophen, and corticosteroids and monitor them for systemic administration-related reactions, particularly before and after the first two injections.¹

The American Cancer Society estimates that this year, there will be 35,780 new cases of NDMM in the United States, with approximately 12,540 deaths expected as a result. The average risk of being diagnosed with NDMM in the United States is one in 103 for men and about one in 131 for women.²

"This latest indication for Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in disease progression or death during first-line treatment when patients are likely to experience their deepest responses," said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, J&J, in the press release. "Today's approval embodies our commitment to setting new standards of care for patients newly diagnosed with multiple myeloma who are transplant eligible."

References

1. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible. J&J. July 30, 2024. Accessed July 31, 2024. https://www.investor.jnj.com/news/news-details/2024/DARZALEX-FASPRO-daratumumab-and-hyaluronidase-fihj-based-quadruplet-regimen-approved-in-the-U.S.-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible/default.aspx

2. Key Statistics About Multiple Myeloma. American Cancer Society. Accessed July 31, 2024. https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html