The U.S. Meals and Drug Administration (FDA) has authorised the usage of Darzalex Faspro (daratumumab and hyaluronidase-fihj) together with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (VRd) for the therapy of adults with newly identified a number of myeloma who’re ineligible for autologous stem cell transplant (ASCT).
The company introduced the approval on its web site on Tuesday, Feb. 27.
The effectiveness of the therapy mixture was evaluated within the CEPHEUS open-label, randomized, active-controlled trial in sufferers with newly identified a number of myeloma who had been ineligible for ASCT or refused ASCT as preliminary remedy. The effectiveness of Darzalex Faspro-VRd has not been established in sufferers who refused ASCT as preliminary remedy, the company famous in its announcement of the approval.
Within the trial, 395 sufferers had been randomized: 197 to the Darzalex Faspro-VRd arm and 198 to the VRd arm. The key efficacy end result measures of the trial had been general minimal residual illness (MRD) negativity charge and progression-free survival (PFS) by impartial overview committee (IRC) primarily based on Worldwide Myeloma Working Group (IMWG) response standards. The MRD negativity charge was 52.3% within the Darzalex Faspro-VRd arm and 34.8% within the VRd arm. The PFS hazard ratio was 0.60.
The company suggested that the prescribing data for the therapy mixture contains warnings and precautions for hypersensitivity and different administration reactions, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity interference with cross-matching and pink blood cell antibody screening, and cardiac toxicity in sufferers with gentle chain (AL) amyloidosis.
Throughout a CURE Educated Affected person® Summit in 2025, Dr. Cesar Rodriguez —an affiliate professor of medication (hematology and medical oncology) on the Icahn Faculty of Drugs at Mount Sinai, The Tisch Most cancers Institute and the Heart of Excellence for A number of Myeloma, and Scientific Director of A number of Myeloma at The Mount Sinai Hospital in New York Metropolis — mentioned the findings of the CEPHEUS trial.
“We see right here that by including this fourth agent to a few brokers, there actually is an additional advantage when it comes to the depth of the response and the management of the illness,” Rodriguez stated through the summit. “And one would say, ‘OK, effectively, why are we doing this in any individual who’s frail or who’s transplant ineligible?’ It is an excellent query, and we have to determine, ‘OK, what’s our aim for the therapy?’ Is our aim the therapy to attain a remission and a sturdy remission, or is the aim of our therapy to only preserve the illness and to maintain it from development? If we actually need to attempt to knock off the illness from the affected person and we need to attempt to get the most effective management potential, then a mixture of 4 medication is feasible, as you possibly can see by this research.”
“These information help the usage of [Darzalex] together with VRd as a traditional customary of care in sufferers with newly identified a number of myeloma who’re transplant ineligible or when transplant is deferred,” Dr. Sonja Zweegman from the Division of Hematology at Amsterdam UMC, Vrije Universiteit Amsterdam, Most cancers Heart Amsterdam, Netherlands, stated throughout a presentation of the info from the CEPHEUS trial on the 2024 ASH Annual Assembly.
This regulatory announcement marks the most recent approval by the FDA for the usage of Darzalex Faspro, which was beforehand authorised by the company in late 2025 for the therapy of adults with high-risk smoldering a number of myeloma.
References
- “FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly identified a number of myeloma,” FDA; https://www.fda.gov/medication/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly
- “Quadruplet Routine Preferable to Triplets in A number of Myeloma,” CURE; https://www.curetoday.com/view/quadruplet-regimen-preferable-to-triplets-in-multiple-myeloma
- “Darzalex Routine Might Enhance MRD Responses in A number of Myeloma,” CURE; https://www.curetoday.com/view/darzalex-regimen-may-improve-mrd-responses-in-multiple-myeloma
- “FDA Approves Darzalex Faspro in Excessive-Threat Smoldering A number of Myeloma,” CURE; https://www.curetoday.com/view/fda-approves-darzalex-faspro-in-high-risk-smoldering-multiple-myeloma
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