Another Win For Darzalex as FDA Approves Combination Treatment For Multiple Myeloma

FDA Approved stamp in red

Using its Real Time Oncology Review pilot program, the U.S. Food and Drug Administration (FDA) approved Janssen and Genmab’s Darzalex (daratumumab) in combination with lenalidomide and dexamethasone as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT).

The FDA gave the combination treatment the green light for those newly diagnosed patients. The approval is based on results from the Phase III MAIA clinical trial, which showed that the Darzalex combination significantly reduced the risk of disease progression or death by 44% compared to treatment with lenalidomide and dexamethasone (Rd) alone. Data from that study was published in the New England Journal of Medicine and was presented at the American Society of Hematology meeting. In addition to the 44% reduction of disease progression, trial data also showed the combination with Darzalex increased rates of complete responses to the treatment, 48% compared to 25% with Rd. The combination also generated strong very good partial responses or better of 79% versus 53% and an overall response of 93% versus 81%. The median progression-free survival had not been reached with the combination treatment, compared to 31.9 months on Rd, Janssen said.

Darzalex targets CD38, a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of the disease. It binds to the protein and inhibits tumor cell growth causing myeloma cell death. Darzalex is the only CD38-directed antibody approved to treat multiple myeloma.

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Saad Usmani, a lead investigator on the MAIA trial and a doctor at the Levine Cancer Institute/Carolinas HealthCare System, said multiple myeloma becomes more difficult to treat after relapse, which is why it’s important for patients to “receive an efficacious upfront therapy with a goal of extending their first remission period.” The combination regimen offers an important frontline treatment option for this patient population, Usmani said in a statement.

“Today's approval of Darzalex underscores the significant clinical benefit of this CD38 monoclonal antibody and our efforts to advance treatment paradigms to change the course of the disease,” Craig Tendler, head of Clinical Development and Global Medical Affairs in Oncology at Janssen Research & Development, said in a statement.

Darzalex was first approved in the United States in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent. In 2016, Darzalex was approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Then, in 2017, it was again approved in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI. Then last year, Darzalex received approval in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT, making it the first monoclonal antibody approved for newly diagnosed patients with this disease.

While Darzalex has been a strong drug in treating multiple myeloma, Janssen and Genmab are already collaborating on a successor to Darzalex with the development of a next-generation CD38 antibody product for the treatment of multiple myeloma and diffuse large B-cell lymphoma.

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