USA — Johnson & Johnson has filed a supplemental Biologics License Application (sBLA) with the US Food and drugs Administration (FDA) for its multiple myeloma (NDMM) medication, DARZALEX FASPRO-based quadruplet regimen.
According to the company’s statement, this application seeks approval for the drug in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma (NDMM) in adult patients who are ineligible for or have deferred autologous stem cell transplantation.
This submission is based on results from the Phase 3 CEPHEUS research (NCT03652064), which found significant improvements for patients treated with D-VRd.
Specifically, 60.9 percent of patients reached minimal residual disease (MRD) negative, and the risk of disease progression or mortality was lowered by 43% when compared to the usual VRd regimen.
The CEPHEUS trial assessed the safety and efficacy of D-VRd in individuals with NDMM for whom ASCT was not considered as an initial treatment.
After a median follow-up of 58.7 months, the D-VRd regimen demonstrated greater depth and durability of response than VRd, with a higher MRD-negativity rate of 60.9 percent against 39.4 percent.
The overall safety profile of D-VRd was consistent with what is already known for DARZALEX FASPRO® and VRd.
Dr. Craig Tendler, Vice President of Late Clinical Development and Global Medical Affairs, Innovative Medicine at Johnson & Johnson, emphasized the importance of DARZALEX FASPRO-based therapies in advancing multiple myeloma research.
He highlighted that the FDA’s Oncologic Drugs Advisory Committee had recently voted in favor of using MRD-negativity as an acceptable endpoint in multiple myeloma clinical trials.
Dr. Tendler also noted that the CEPHEUS study is Johnson & Johnson’s first registrational trial to use MRD-negativity as a primary endpoint in the treatment of multiple myeloma.
The data from CEPHEUS, alongside the results from the PERSEUS study, further support the potential benefits of the D-VRd quadruplet regimen for patients newly diagnosed with multiple myeloma, regardless of their eligibility for a transplant.
Multiple myeloma, a type of blood cancer affecting plasma cells in the bone marrow, remains the second most common blood cancer globally.
In 2024, over 35,000 new cases of multiple myeloma are expected to be diagnosed in the U.S., with more than 12,000 deaths anticipated.
Despite advances in treatment, multiple myeloma remains incurable, with a 5-year survival rate of 59.8 percent.
Symptoms can range from bone fractures and pain to kidney problems, fatigue, and recurrent infections, though some patients may show no symptoms at the time of diagnosis.
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