The FDA is set to review a Darzalex Faspro-based regimen for potential approval for patients with newly diagnosed multiple myeloma who are transplant-ineligible.
Johnson & Johnson submitted a supplemental biologics license application to the Food and Drug Administration (FDA) to potentially approve a new indication for a Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimen to treat adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The regimen includes Darzalex Faspro in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone, a regimen referred to as D-VRd, as noted in a press release from Johnson & Johnson, the manufacturer of Darzalex Faspro.
Of note, a drug manufacturer submits a supplemental biologics license application to the FDA when seeking approval of a new indication for a drug that has been previously approved for a different indication.
The submission of this supplemental biologics license application is based on findings from the phase 3 CEPHEUS study, according to the release. Researchers conducting the trial evaluated the safety and efficacy of D-VRd versus Velcade, Revlimid and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma for whom autologous stem cell transplant was not the initial therapy.
Results from this trial showed that 60.9% of patients treated with D-VRd achieved minimal residual disease (MRD)-negativity and a 43% reduction in the risk for progression or death.
According to the National Cancer Institute, MRD refers to a very small number of cancer cells in the body during or after treatment. Testing for MRD may help care teams plan treatment, determine how a treatment option is working, make a prognosis or determine whether the disease has returned. MRD negativity means that there is little to no disease remaining in the blood after treatment.
“Darzalex Faspro-based therapies continue to be at the forefront of multiple myeloma research,” Dr. Craig Tendler, Vice President of Late Clinical Development and Global Medical Affairs at Johnson & Johnson Innovative Medicine, said in the release. “We’re encouraged that the FDA Oncologic Drugs Advisory Committee recently voted in favor of MRD-negativity as an acceptable endpoint in multiple myeloma trials. CEPHEUS is the first registrational study with a primary endpoint of MRD-negativity filed by Johnson & Johnson in multiple myeloma.”
In addition, the rate of overall complete response (the percentage of patients whose disease completely disappeared from treatment) or better from treatment was higher in the D-VRd group compared with the VRd group (81.2% versus 61.6%).
“The data from CEPHEUS add to the body of evidence for Darzalex Faspro in newly diagnosed multiple myeloma and, together with the results of the PERSEUS study, demonstrate the potential benefit of this quadruplet regimen for newly diagnosed patients regardless of transplant eligibility,” Tendler said in the release.
Findings from the PERSEUS study were recently presented at the 2024 SOHO Annual Meeting. Results demonstrated that 57.5% of transplant-eligible patients with newly diagnosed multiple myeloma treated with D-VRd were MRD negative compared with 32.5% of those treated with VRd.
“These data further highlight the benefit of D-VRd and [Darzalex plus Revlimid] maintenance as a new standard of care for transplant-eligible patients with newly diagnosed multiple myeloma,” study author Dr. Meletios A. Dimopoulos, of the University of Athens School of Medicine in Greece, said during the presentation at the SOHO Annual Meeting.
Darzalex Faspro has been previously approved by the FDA for other indications and in different combinations. Approvals started in 2020 and included Darzalex Faspro alone for patients with newly diagnosed or relapsed/refractory multiple myeloma. In 2021, Darzalex Faspro was approved for use with pomalidomide and dexamethasone to treat patients with multiple myeloma who previously received at least one prior therapy including lenalidomide and a proteasome inhibitor. In the same year, the drug received FDA approval for use with Kyprolis (carfilzomib) plus dexamethasone for adults with relapsed or refractory multiple myeloma who received one to three prior treatments. In July 2024, D-VRd was approved for use as induction and consolidation in patients with multiple myeloma.
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