NEW BRUNSWICK (dpa-AFX) - Drug major Johnson & Johnson (JNJ) announced Tuesday that DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) -based quadruplet regimen has received the U.S. Food and Drug Administration approval to treat adult patients with newly diagnosed multiple myeloma or NDMM, who are ineligible for autologous stem cell transplant (ASCT).
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone or D-VRd has received the approval. The company noted that D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.
Multiple myeloma, a blood cancer that affects a type of white blood cell called plasma cells found in the bone marrow, is the second most common blood cancer worldwide and remains an incurable disease. It is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S. in 2026, iand more than 12,000 will die from the disease.
The approval was based on the results of the pivotal Phase 3 CEPHEUS study (NCT03652064), which evaluated the efficacy and safety of D-VRd compared to bortezomib, lenalidomide and dexamethasone (VRd) in NDMM patients who were ineligible for ASCT or deferred ASCT as initial therapy. The latest milestone follows approval for D-VRd for the treatment of patients who are newly diagnosed with multiple myeloma and eligible for ASCT.
DARZALEX is the first CD38-directed antibody approved to treat multiple myeloma. It received U.S. FDA approval in November 2015 and is approved in eight indications.
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for eleven indications in multiple myeloma.
In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide deal, which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab.
June Lanoue, U.S. President, Hematology, Johnson & Johnson Innovative Medicine, said, 'This approval marks the twelfth indication for DARZALEX FASPRO overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory patients. CEPHEUS demonstrated the efficacy of a DARZALEX FASPRO-based quadruplet as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure.'
J&J shares closed Tuesday's regular trading 1.3 percent higher at $224.44. In the overnight trading, the shares were gaining 0.5 percent further, trading at $225.50.
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