Daratumumab
The CD38 antibody that turned triplets into quadruplets: adding it to standard induction roughly halves the risk of myeloma progressing.
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.
1.Binds CD38 on the plasma cell surface
- Route
- Subcutaneous 1,800 mg (or IV 16 mg/kg)
- Schedule
- Weekly × 8, every 2 weeks × 8, then every 4 weeks
- Monitoring
- Injection/infusion reactions (first dose), infections, interference with blood typing and M-protein assays, HBV reactivation
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9145 (IV); Darzalex Faspro (subcutaneous) is clinician-administered and Part B.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Johnson & Johnson withMe
- Johnson & Johnson Patient Assistance Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- With bortezomib and dexamethasone for myeloma after 1 prior therapy (CASTOR)
- Notes
- Monotherapy after 3 lines: TA510 (2018, CDF). D-VTd induction before transplant: TA783 (2022). DVd moved to routine: TA763 (2022). D-Rd for untreated transplant-ineligible myeloma recommended 2023-24. Subcutaneous form used throughout.
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA573 · NHS England Cancer Drugs Fund list · SMC advice: daratumumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 16 Nov 2015ApprovalUS
First CD38 antibody
- 1 May 2020ApprovalUS
Subcutaneous Darzalex Faspro
- 30 Jul 2024ApprovalUS
Dara-VRd induction/consolidation (PERSEUS)
- 5 Mar 2026ApprovalUS
Teclistamab + daratumumab after ≥1 prior line source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Relapsed myeloma after ≥3 lines |
| US | 2019 | Newly diagnosed, transplant-ineligible with Rd (MAIA) and VMP |
| US | 2024 | Newly diagnosed transplant-eligible with VRd (PERSEUS) |
| US | 2026 | With teclistamab after ≥1 line (MajesTEC-3); high-risk smouldering myeloma (AQUILA) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Infusion/injection reaction subcutaneous (COLUMBA) | 13% | 1% |
| Neutropenia (with Rd) MAIA | — | 50% |
| Pneumonia MAIA | — | 14% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
CEPHEUS extends the quadruplet standard to patients who are not going to transplant, closing the gap between transplant-eligible and ineligible populations. It is also one of the first phase 3 trials to be designed around MRD-negativity as the primary endpoint, which could shorten future myeloma trials by years. Frailer patients still need dose-adapted approaches.
PERSEUS, with the earlier GRIFFIN and CASSIOPEIA trials, made a four-drug daratumumab quadruplet the standard for fit patients heading to transplant. It also introduced MRD-directed stopping of the antibody, a step towards treatment that is deep but not indefinite. Whether transplant itself remains necessary on top of a quadruplet is now the open question.
CARTITUDE-4 is the first randomised trial to show that a CAR-T improves survival in myeloma, and it moved cilta-cel into second-line use (FDA approval 2024). For patients whose disease returns after first-line lenalidomide, a one-off cell therapy now competes with continuous drug combinations. Capacity, cost and the need for bridging therapy still limit who actually receives it.
MAIA made a daratumumab-based triplet the standard first treatment for older or frail myeloma patients, replacing Rd alone. It proved an anti-CD38 antibody could improve survival, not just delay progression, when used up front. Quadruplets built on this backbone are now being tested in the same population.
Latest papers
topQuery for this drug: (TITLE:"Daratumumab" OR ABSTRACT:"Daratumumab" OR TITLE:"Darzalex" OR ABSTRACT:"Darzalex" OR TITLE:"Darzalex Faspro" OR ABSTRACT:"Darzalex Faspro") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Daratumumab, not a curated reading list.