FDA Grants Approval to Daratumumab and Hyaluronidase With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed MM
On January 27, 2026, the US Food and Drug Administration (FDA) granted approval to daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).
Approval was based on efficacy evaluations from open-label, randomized, active-controlled trial CEPHEUS. The trial was conducted among patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy, however, the effectiveness of the combination has not been established yet in patients who refused ASCT as initial therapy.
In this trial a total of 395 patients were randomized, 197 to the daratumumab plus hyaluronidase-fihj and VRd arm, and 198 to the VRd arm. Major efficacy outcome measures utilized were overall minimal residual disease (MRD) negativity rate and progression-free survival (PFS) as assessed by independent review committee (IRC) based on International Myeloma Working Group (IMWG) response criteria.
The MRD negativity rate was 52.3% in the daratumumab plus hyaluronidase-fihj and VRd arm and 34.8% in the VRd arm ( P = 0.0005). The PFS hazard ratio was 0.60 [95% confidence interval [CI], 0.41 to 0.88]; P = 0.0078].
As for safety, the prescribing information includes warnings for hypersensitivity and other administration reactions, , infections, neutropenia, thrombocytopenia, embryo-fetal toxicity interference with cross-matching and red blood cell antibody screening, and cardiac toxicity in patients with light chain (AL) amyloidosis.
Source:
US Food and Drug Administration. FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. Accessed January 27, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly
