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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.
Backbone ribbon from PDB 7DHA. RCSB PDB 7DHA. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Human IgG1κ anti-CD38: CDC, ADCC, ADCP, apoptosis via Fc crosslinking, and depletion of CD38+ regulatory T and B cells. Connects to CD38.
1.Binds CD38 on the plasma cell surface
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.
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.
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.
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.
Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent
First CD38 antibody
Multiple myeloma after at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or double refractory to a proteasome inhibitor and an immunomodulatory agent
Confirmed: the accelerated approval of 2015 converted to traditional approval 1.0 year after it was granted.
Subcutaneous Darzalex Faspro
Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
Dara-VRd induction/consolidation (PERSEUS)
Treatment of patients with light chain (AL) amyloidosis in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed patients
Confirmed: the accelerated approval of 2021 converted to traditional approval 4.8 years after it was granted. source
Teclistamab + daratumumab after ≥1 prior line source
FDA grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma source
| 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.
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Early single-agent treatment of high-risk smouldering myeloma is now an option with regulatory approval, though monitoring remains acceptable and the definition of high risk matters.
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.
Quadruplet induction with a CD38 antibody became the standard for transplant-eligible patients in Europe. PERSEUS later did the same with the lenalidomide-based backbone used elsewhere.
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.
Query 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.
Shares A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela, A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple.
Shares A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma , Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma, A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, CASSIOPEIA: daratumumab added to bortezomib, thalidomide and dexamethasone before and after transplant in newly diagnosed myeloma.
Shares A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul, DRAMMATIC, A Study of Daratumumab, A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-spe.
Shares A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and/or Oral Antimyeloma , A Study of Daratumumab, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela, A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA).
Shares A Study of the Efficacy and Safety of BCD-248 in Combination With Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma (AMMADINA), A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lena, A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination Wi, A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethas.
Shares Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT, CD38 antibody added to PI-IMiD-dex (quadruplet induction), CD38 expression, Complement in cancer.
Shares MRD-guided treatment-free intervals in myeloma, PERSEUS, MAIA: adding daratumumab to lenalidomide-dexamethasone for older patients with newly diagnosed myeloma who cannot have a transplant, CEPHEUS: daratumumab quadruplet for newly diagnosed myeloma patients not having a transplant, with MRD-negativity as the main endpoint.
Shares A Study of Daratumumab, A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-spe, A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Rela, A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple.