{"entity":{"id":"daratumumab","kind":"drug","name":"Daratumumab","aka":[],"tldr":"The CD38 antibody that turned triplets into quadruplets: adding it to standard induction roughly halves the risk of myeloma progressing.","summary":"First approved 2015 (monotherapy after ≥3 lines); now in frontline quadruplets: Dara-VRd (PERSEUS, transplant-eligible; CEPHEUS, transplant-ineligible), Dara-Rd (MAIA, OS benefit), Dara-VMP (ALCYONE). Subcutaneous Faspro (2020) gives a 5-minute injection. Approved in high-risk smouldering myeloma (AQUILA, 2025-26) and with teclistamab (MajesTEC-3, March 2026). Also used in AL amyloidosis. J&J/Genmab.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Daratumumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Daratumumab"}],"tags":[],"related":[],"cancers":["multiple-myeloma","smouldering-myeloma","myeloma-transplant-eligible","myeloma-transplant-ineligible","plasma-cell-leukaemia"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd38"],"drugs":[],"companies":["johnson-johnson","genmab","halozyme"],"institutions":[],"pathways":[],"terms":["adcc"],"trials":["perseus","cepheus","majestec-3","nct06868654","nct06952478","nct06464991","nct05438043","nct05623020","nct04975997","nct05020236","nct07095452","nct06679101","nct06868667","nct05552222","nct05455320","nct07393282","nct02343042","nct03314181","nct04133636","nct03989414","nct06577025","nct04782687","nct06892522","nct06119685","nct06953960","nct07681596","nct04973605","nct02773030","nct07742215"],"people":[],"bottlenecks":[],"keyPapers":["paper-aquila-daratumumab-smouldering-nejm-2025","paper-cassiopeia-lancet-2019","paper-maia-daratumumab-rd-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"brand":"Darzalex / Darzalex Faspro (SC)","modality":"Monoclonal antibody (anti-CD38)","mechanism":"Human IgG1κ anti-CD38: CDC, ADCC, ADCP, apoptosis via Fc crosslinking, and depletion of CD38+ regulatory T and B cells.","approvals":[{"region":"US","year":2015,"indication":"Relapsed myeloma after ≥3 lines"},{"region":"US","year":2019,"indication":"Newly diagnosed, transplant-ineligible with Rd (MAIA) and VMP"},{"region":"US","year":2024,"indication":"Newly diagnosed transplant-eligible with VRd (PERSEUS)"},{"region":"US","year":2026,"indication":"With teclistamab after ≥1 line (MajesTEC-3); high-risk smouldering myeloma (AQUILA)"}],"mechanismSteps":["Binds CD38 on the plasma cell surface","Recruits complement (CDC) and Fc-receptor effector cells (ADCC, ADCP)","Crosslinking triggers direct apoptosis","Depletes CD38-high immunosuppressive cells, freeing T cells"],"dosing":{"route":"Subcutaneous 1,800 mg (or IV 16 mg/kg)","schedule":"Weekly × 8, every 2 weeks × 8, then every 4 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inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent"},{"date":"2020-05-01","type":"approval","region":"US","note":"Subcutaneous Darzalex Faspro"},{"date":"2021-01-15","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis","indication":"Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients"},{"date":"2024-07-30","type":"approval","region":"US","note":"Dara-VRd induction/consolidation (PERSEUS)"},{"date":"2025-11-19","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2021 converted to traditional approval 4.8 years after it was granted.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis","indication":"Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients"},{"date":"2026-03-05","type":"approval","region":"US","note":"Teclistamab + daratumumab after ≥1 prior line","source":"https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-u-s-fda-approval-of-tecvayli-plus-darzalex-faspro-for-relapsed-refractory-multiple-myeloma-offering-a-potential-new-standard-of-care-as-early-as-second-line"},{"date":"2026-08-13","type":"approval","region":"US","note":"FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple 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