FDA

Darzalex Faspro combo OK’d for newly diagnosed multiple myeloma

January 29, 2026

On January 27, 2026, FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Efficacy

Efficacy was evaluated in the phase 3 CEPHEUS trial (NCT03652064) involving patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy. Note: The effectiveness of D-VRd has not been established in patients who refused ASCT as initial therapy.

A total of 395 patients were randomized: 197 to the D-VRd arm and 198 to the VRd arm. The major efficacy outcome measures were overall minimal residual disease (MRD) negativity rate and progression-free survival (PFS). The MRD negativity rate was 52.3% in the D-VRd arm and 34.8% in the VRd arm (p-value 0.0005). PFS hazard ratio was 0.60 (95% confidence interval, 0.41-0.88; p-value 0.0078).

Safety

The most common adverse reactions (≥20%) reported in ASCT-ineligible patients with multiple myeloma who received D-VRd were upper respiratory tract infection, sensory neuropathy, musculoskeletal pain, diarrhea, fatigue, edema, rash, motor dysfunction, COVID-19, constipation, sleep disorder, cough, pneumonia, renal impairment, dizziness, nausea, urinary tract infection, pyrexia, abdominal pain, dyspnea, decreased appetite, and bruising.

Sources:

FDA approved daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly

Darzalex Faspro (daratumumab and hyaluronidase-fihj) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761145s028lbl.pdf Revised January 2026. Accessed January 28, 2026.

Darzalex Faspro®-based quadruplet regimen approved in the US for newly diagnosed patients with multiple myeloma who are transplant ineligible. [News release]. 2025. https://www.jnj.com/media-center/press-releases/darzalex-faspro-based-quadruplet-regimen-approved-in-the-u-s-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible