Health
DARZALEX FASPRO®-based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplan
About this update from Johnson & Johnson
[{"type":"text","content":"Quadruplet regimen demonstrated significantly deeper and more durable responses, higher MRD negativity and improved progression-free survival versus a standard of care ","length":183,"tagName":"p"},{"type":"text","content":"Approval marks the twelfth indication for DARZALEX FASPRO® and fifth in the newly diagnosed setting, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory multiple myeloma patients","length":226,"tagName":"p"},{"type":"text","content":"HORSHAM, Pa., Jan. 27, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.","length":647,"tagName":"p"},{"type":"image","alt":"Johnson & Johnson (PRNewsfoto/Johnson & Johnson)","displaySize":"","headline":null,"caption":"Johnson & Johnson (PRNewsfoto/Johnson & Johnson)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":38,"url":"https://media.zenfs.com/en/prnewswire.com/7666cc68e9666a174bca3f07e3f94721"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/l1P3ZFYFL52xeQr0zq6rKg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTY3O2NmPXdlYnA-/https://media.zenfs.com/en/prnewswire.com/7666cc68e9666a174bca3f07e3f94721","width":400,"height":38}},"href":"https://mma.prnewswire.com/media/2343818/Johnson_and_Johnson_Logo_v1.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"The pivotal Phase 3 CEPHEUS study (NCT03652064) 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.1 Today's milestone follows approval for D-VRd for the treatment of patients who are newly diagnosed with multipl...