SUMMARY

• Johnson & Johnson does not recommend the use of DARZALEX for intravenous (IV) use or DARZALEX FASPRO for subcutaneous (SC) use in a manner that is inconsistent with the approved labeling.
• Among the 4 studies of DARZALEX FASPRO for SC use summarized below (COLUMBA,¹ ANDROMEDA,² PERSEUS,³ and AQUILA⁴), all doses of DARZALEX FASPRO were to be administered at outpatient visits per their clinical trial protocols.
• Among the 7 studies of DARZALEX for IV use summarized below (GEN501,⁵ SIRIUS,⁶ GRIFFIN,⁷ POLLUX,⁸ CASTOR,⁹ CASSIOPEIA,^10,11 and MAIA¹²), all doses of DARZALEX were to be administered at outpatient visits per their clinical trial protocols.

• Binder et al (2024)¹³ presented results from an open-label, single-arm study that assessed implementation of home-based administration of DARZALEX FASPRO for patients with multiple myeloma (MM). No significant difference was identified in the primary outcome (Satisfaction with Therapy [SWT] score) and secondary outcome (quality of life [QoL]) when comparing home care (HC) with treatment at the infusion center. No unique adverse events (AEs) related to home administration and no unexpected AEs related to medications were reported.
• Lund et al (2024)¹⁴ presented results from a study that assessed administration of DARZALEX outside the hospital as well as the effectiveness of electronic patient-reported outcome (PRO) data for pretreatment evaluation of whether patients needed to talk to a healthcare practitioner before each injection.
  • Of the of 269 planned DARZALEX administrations, 125 were hospital-planned administrations and 144 were planned to be given outside the hospital.¹⁴
  • On average, patients saved 177 minutes per administration given at home (29 minutes) vs the hospital (206 minutes).¹⁴
• De Angelis et al (2023)¹⁵ presented results of DARZALEX FASPRO administered at home to frail patients with MM. Among 12 patients who were evaluable for response, 1 achieved stringent complete remission (sCR) and 4 achieved very good partial remission (VGPR), yielding an overall response rate (ORR) of 42%; furthermore, 5 patients had stable disease (SD), and 2 patients had progressive disease (PD). The main AEs that occurred during domiciliary treatment included infections (pneumonia [n=4], sepsis [n=2], cystitis [n=1]), and deep vein thrombosis (n=1). In the long-term residential accommodation (LTRA) group, 80% of patients (4/5) experienced infections, which were fatal in 3 cases. Conversely, in the HC group, 30% of patients (3/10) experienced infections, with only 1 resulting in death. At the last follow-up, 8 patients were alive (2 were awaiting a transplant procedure) and 7 patients were reported to have died (PD, n=3; infective complications, n=3; and heart disease, n=1).

PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf 
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf

CLINICAL PROTOCOLS

• Among the 4 studies of DARZALEX FASPRO for SC use summarized below, all doses of DARZALEX FASPRO were to be administered at outpatient visits per their clinical trial protocols.
  • COLUMBA (MMY3012) was a phase 3, randomized, open-label, multicenter, non-inferiority study evaluating the efficacy, pharmacokinetics, and safety of DARZALEX vs DARZALEX FASPRO in patients with relapsed or refractory multiple myeloma (RRMM).¹
    • All doses of DARZALEX or DARZALEX FASPRO were to be administered at outpatient visits.¹⁶
  • ANDROMEDA (AMY3001) was a prospective, randomized, active-controlled, multicenter, phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared to bortezomib, cyclophosphamide, and dexamethasone (VCd) alone in newly diagnosed patients with systemic immunoglobulin light-chain amyloidosis.²
    • All doses of DARZALEX FASPRO were performed as outpatient visits.¹⁷
  • PERSEUS (MMY3014) is an ongoing, open-label, multicenter, randomized, phase 3 study evaluating the efficacy and safety of DARZALEX FASPRO in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) vs bortezomib, lenalidomide, and dexamethasone (VRd) induction and consolidation followed by maintenance with lenalidomide and daratumumab (D-R) in D-VRd group or lenalidomide (R) in VRd group in patients with newly diagnosed multiple myeloma (NDMM) eligible for autologous stem cell transplant (ASCT).³ 
    • All injections of DARZALEX FASPRO will be administered in an outpatient setting.¹⁸  
  • AQUILA (SMM3001) is an ongoing, phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of DARZALEX FASPRO versus active monitoring in patients with high-risk smoldering multiple myeloma (HR-SMM).⁴ 
    • All doses of DARZALEX FASPRO will be administered at outpatient visits.¹⁹ 
• Among the 7 studies of DARZALEX for IV use summarized below, all doses of DARZALEX were to be administered at outpatient visits per their clinical trial protocols.
  • GEN501 was an open-label, multicenter, dose-escalating (Part 1) and dose-expansion (Part 2) phase 1/2 study assessing the safety of DARZALEX monotherapy in patients with MM who had relapsed after or were refractory to ≥2 prior lines of therapy, including proteasome inhibitors (PIs), immunomodulatory agents, chemotherapy, and ASCT.⁵
    • All infusions during part 2 of the study were performed as outpatient visits.²⁰
  • SIRIUS (MMY2002) was an open-label, multicenter, international, phase 2 study evaluating the efficacy and safety of DARZALEX monotherapy in patients with MM who have received ≥3 prior lines of therapy, including a PI and an immunomodulatory agent, or have disease refractory to both a PI and an immunomodulatory agent.⁶
    • All infusions were performed as outpatient visits.²¹
  • GRIFFIN (MMY2004) was a 2-part, open-label, multicenter, phase 2, randomized, active-controlled study in United States evaluating the safety and efficacy of DARZALEX in combination with VRd in patients with NDMM eligible for high-dose therapy and ASCT.⁷
    • All infusions were planned as outpatient visits.²²
  • POLLUX (MMY3003) was a randomized, open-label, multicenter, phase 3 study evaluating the safety and efficacy of lenalidomide and dexamethasone (Rd) and DARZALEX + Rd in patients with RRMM.⁸
    • All infusions could be performed as outpatient visits.²³
  • CASTOR (MMY3004) was a multicenter, randomized, open-label, active controlled, phase 3 study that evaluated the safety and efficacy of bortezomib and dexamethasone (Vd) alone and DARZALEX + Vd in patients with RRMM.⁹
    • All infusions were planned as outpatient visits.²⁴
  • CASSIOPEIA (MMY3006) was an open-label, randomized, multicenter, active-controlled study evaluating the safety and efficacy of treatment with bortezomib, thalidomide, and dexamethasone (VTd) alone and DARZALEX + VTd in patients with NDMM eligible for ASCT.^10,11
    • In MMY3006, all infusions were planned as outpatient visits.²⁵
  • MAIA (MMY3008) was an international, phase 3, randomized, open-label, active-controlled, multicenter study evaluating the safety and efficacy of DARZALEX in combination with Rd compared to Rd in transplant-ineligible patients with NDMM.¹²
    • All infusions were planned as outpatient visits.²⁶

CLINICAL DATA

Binder et al (2024)¹³ presented results from an open-label, single-arm study (from December 9, 2022, to April 17, 2024) that assessed implementation of home-based administration of DARZALEX FASPRO for patients with MM.

Methods

• Overall, 20 patients (mean age, 66 years [range, 49-89]) who were receiving DARZALEX FASPRO monthly as either monotherapy or in combination with oral agents for MM were included in the study.¹³
  • Ten patients (50%) were female, and 10 patients (50%) identified as Black or African American.
  • One patient withdrew from the trial after cycle 2, and 1 patient came off the trial for cycle 8 after significant treatment delays due to infectious complications.
  • Nineteen patients completed the home infusion portion of the study.
• Patients received 8 cycles of DARZALEX FASPRO (2 cycles at the infusion center, followed by 4 cycles at home and 2 cycles again at the infusion center).¹³
• Primary endpoint: patients’ treatment satisfaction, assessed using the SWT domain of the Cancer Therapy Satisfaction Questionnaire (CTSQ), when receiving HC vs standard-of-care treatment at the infusion center.¹³
• Secondary endpoints: adherence to home therapy, safety of home administration, barriers to home administration, QoL (EORTC QLG Core Questionnaire [EORTC QLQ-C30]), financial burden (COST survey), and other CTSQ domains.¹³
  • Surveys were completed at each monthly visit, and semistructured qualitative interviews were conducted at the end of the study.

Results

• No significant difference in the primary outcome (SWT score) was identified when comparing HC vs treatment at the infusion center (mean difference, 0.7 in favor of treatment at the infusion center; 95% confidence interval, -3.02 to 1.62; P=0.551).¹³
  • Treatment adherence at home was 100%, with minimal delays in therapy (1/76 [1.4%]).
  • No barriers to home administration were identified.
  • There were no unique AEs related to home administration and no unexpected AEs related to medications.
• No significant differences in the secondary outcomes were identified when comparing HC vs treatment at the infusion center.¹³
  • The EORTC QLQ-C30 mean difference between HC and treatment at the infusion center was 2.08 (P=0.405).
  • Regardless of the treatment site, females experienced a significantly higher financial toxicity vs males (COST score, 7.37 points; P=0.026).
  • There was no noticeable impact of home administration on COST score (0.18 points; P=0.812).

Lund et al (2024)¹⁴ presented results from a study that assessed administration of DARZALEX outside the hospital (by a district nurse at home or in a local healthcare clinic) as well as the effectiveness of electronic PRO data for pretreatment evaluation of whether patients needed to talk to a healthcare practitioner before each injection.

• Of the 269 planned DARZALEX administrations, 125 were hospital-planned administrations and 144 were planned to be given outside the hospital.¹⁴
  • Of the 125 hospital-planned administrations, 122 (97.6%) were given and 1 was cancelled.
  • Of the 144 outsource administrations, 133 (92.4%) were given as planned, 6 were redirected and given at the hospital (2 due to suspicion of infection and 4 for administrative reasons), and 5 were cancelled.
• On average, patients saved 177 minutes per administration given at home (29 minutes) vs the hospital (206 minutes).¹⁴
  • For patients treated at home, time was reduced by a factor of 3.25 (home vs local healthcare clinic: 63 minutes vs 205 minutes, respectively).
• The number of unplanned health contacts did not differ significantly between home and hospital administrations.¹⁴
• Overall, 84% of patients preferred to continue with home treatment.¹⁴
• The PRO questionaries had a positive predictive value of 100%.¹⁴
  • Prior to each treatment, patients reported their side effects electronically and an algorithm was developed to stratify patients as ready or not for planned treatment.
  • In 171 of 223 cases, the algorithm recommended treatment; in 52 cases, it recommended medical evaluation.
  • Among these 52 cases, 44 received planned treatment and 8 were cancelled/postponed.
• Only 40% of patients preferred to receive calls from the nurse prior to each treatment afterward; furthermore, 52% of patients preferred to continue reporting side effects via the application.¹⁴

De Angelis et al (2023)¹⁵ presented results of a study of DARZALEX/DARZALEX FASPRO administered to frail patients with MM in an outpatient setting.

Results

Baseline Patient Characteristics

• Per the MyelHome project, 15 patients with MM were treated as outpatients. Of these, 10 received HC and 5 received care in LTRA.¹⁵
• Patients received 2 initial doses of either DARZALEX or DARZALEX FASPRO at a hospital to mitigate side effects and received subsequent doses as outpatients. The first outpatient dose was administered by both a nurse and a physician, whereas subsequent doses were administered by nurses only.¹⁵
• Overall, 110 administrations of DARZALEX FASPRO were performed by Domiciliary Hematologic Care Unit nurses in an outpatient setting.¹⁵
• Baseline patient characteristics are summarized in Table: Baseline Characteristics (MyelHome Project).

Efficacy

• Among 12 patients who were evaluable for response, 1 achieved sCR and 4 achieved VGPR (ORR, 42%); furthermore, 5 and 2 patients had SD and PD, respectively.¹⁵

Safety

• During and/or immediately following home administration, 1 patient experienced a grade 2 allergic reaction (per World Health Organization classification); thus, DARZALEX FASPRO was permanently discontinued after the second dose was administered.¹⁵
• The main AEs that occurred during domiciliary treatment included infections (pneumonia [n=4], sepsis [n=2], cystitis [n=1]), and deep vein thrombosis (n=1).¹⁵
• In the LTRA group, 80% of patients (4/5) experienced infections, which were fatal in 3 cases. Conversely, in the HC group, 30% of patients (3/10) experienced infections, with only 1 resulting in death.¹⁵
• At the last follow-up, 8 patients were alive (2 of whom were awaiting a transplant procedure) and 7 patients were reported to have died (PD, n=3; infective complications, n=3; and heart disease, n=1).¹⁵
  
  
  
  

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® Drug File databases (and/or other resources, including internal/external databases) was conducted on 8 January 2026 pertaining to this topic.