FDA approves Darzalex Faspro quadruplet for transplant‑ineligible myeloma

Johnson & Johnson announced that the U.S. Food and Drug Administration approved DARZALEX FASPRO (daratumumab and hyaluronidase‑fihj) in combination with bortezomib, lenalidomide and dexamethasone, the quadruplet regimen known as D‑VRd, for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The company disclosed the approval in a press release datelined Horsham, Pa., on Jan. 27, 2026.

The approval extends the label for DARZALEX FASPRO, the subcutaneous formulation of the anti‑CD38 antibody daratumumab co‑formulated with recombinant human hyaluronidase PH20 (rHuPH20) using ENHANZE drug‑delivery technology. Johnson & Johnson called the nod the product’s twelfth overall indication and its fifth in newly diagnosed multiple myeloma, and characterized D‑VRd as the only anti‑CD38 antibody‑based regimen now approved across newly diagnosed patients regardless of transplant eligibility.

Regulatory clearance was supported by data from the phase 3 CEPHEUS trial (NCT03652064). Trial results showed that adding subcutaneous daratumumab to the standard VRd triplet improved minimal residual disease (MRD)‑negativity rates and progression‑free survival in the study population. CEPHEUS used MRD‑negativity as a primary endpoint, and the superiority of D‑VRd over VRd was highlighted in presentations at medical meetings.

“These data support the use of [Darzalex] in combination with VRd as a normal standard of care in patients with newly diagnosed multiple myeloma who are transplant ineligible or when transplant is deferred,” said Dr. Sonja Zweegman of Amsterdam UMC, a commentator during the CEPHEUS presentation. An industry expert identified as Usmani noted that “MRD‑negativity is a potential predictor of prolonged progression‑free and overall survival,” underscoring why regulators considered the endpoint meaningful for frontline approval.

Johnson & Johnson framed the authorization as a milestone for frontline therapy. June Lanoue, U.S. president, hematology, Johnson & Johnson Innovative Medicine, said the approval “underscor[es] [DARZALEX FASPRO’s] role as foundational therapy for both newly diagnosed and relapsed/refractory patients,” and that CEPHEUS established the efficacy of a DARZALEX FASPRO‑based quadruplet as a frontline standard of care.

Clinicians will evaluate the approval against practical considerations of tolerability, comorbidity and logistics. The subcutaneous formulation offers a shorter administration time than intravenous daratumumab, a factor cited by physicians in assessing patient convenience and clinic throughput. The regimen combines four agents with overlapping toxicities and requires attention to infection risk, blood count suppression and neuropathy.

Prescribing information accompanying the approval reiterates known risks for DARZALEX FASPRO, including hypersensitivity reactions, infections, neutropenia and thrombocytopenia. The label also warns of cardiac toxicity in patients with AL amyloidosis and notes that the overall safety profile aligns with the known effects of the regimen’s component drugs. Common adverse events reported in CEPHEUS included infections and neuropathy.

The FDA authorization adds a new option for patients who cannot undergo autologous stem cell transplant and may shift practice patterns toward quadruplet induction for a broader population of newly diagnosed patients. Physicians seeking dosing details and full safety language should consult the approved prescribing information and the CEPHEUS publications for complete trial data.