SUMMARY

• Janssen cannot recommend any practices, procedures or practice guidelines that deviate from the product labeling or are not approved by the regulatory agencies.
• Currently there are no systemically collected data available regarding restarting after prolonged interruptions with DARZALEX for intravenous (IV) use or DARZALEX FASPRO for subcutaneous (SC) use.
• Kim et al (2019)¹ presented the results of a retrospective chart review evaluating the efficacy and safety of reinitiation of DARZALEX after an interruption in previous DARZALEX-based treatment.
• CASSIOPEIA is a phase 3 study evaluating the safety and efficacy of DARZALEX + bortezomib, thalidomide, and dexamethasone (D-VTd) in transplant eligible patients with previously untreated multiple myeloma (MM).^2,3
  • The median gap in time from the last infusion of DARZALEX during induction treatment to the first infusion of DARZALEX during consolidation was 3.75 months.⁴

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 DATA

Retrospective Chart Review on Reinitiation of DARZALEX after Interruption

Kim et al (2019)¹ presented the results of a retrospective chart review evaluating the efficacy and safety of reinitiation of DARZALEX after an interruption in previous DARZALEX-based treatment.

Study Design/Methods

• Inclusion criteria: patients who received DARZALEX as a prior line of therapy and were reinitiated on DARZALEX after an interruption of >8 weeks.

Results

Patient Characteristics

• Overall, 19 patients were included who were reinitiated on DARZALEX after a treatment break.
  • Among the included patients, treatment was interrupted due to progressive disease (PD) in 8 (42%) patients and due to delay in the same therapy in 11 (58%) patients. Patients who had treatment interruption due to PD had received other therapies before restarting DARZALEX.
• Upon reinitiation, 3 patients received DARZALEX as a first dose (1000 mL infused over 7 hours) and 16 patients received as a non-first dose (500 mL infused at a rapid rate over 90 minutes [n=6] and a second dose over 4 hours [n=10]).
• The duration of treatment interruption ranged from 54-931 days and the number of DARZALEX doses received prior to reinitiation ranged from 2-25.
• Among 8 patients who were reinitiated on a different DARZALEX-based regimen upon progression, the number of subsequent lines of therapy after the initial DARZALEX regimen ranged from 1-7. The duration of therapy upon reinitiation ranged from 1-14 doses.

Safety

• No patients reported IRRs upon reinitiation.

Efficacy

• The response rates after retreatment were variable and generally lower than the initial response.

DARZALEX in Combination with Bortezomib, Thalidomide, and Dexamethasone

CASSIOPEIA (MMY3006; NCT02541383) is an open-label, 2-arm, multicenter, randomized, phase 3 study evaluating the safety and efficacy of D-VTd in patients with previously untreated MM who are eligible for high-dose therapy (HDT) and autologous stem cell transplant (ASCT).^2,3

Results

• In the D-VTd arm, the median gap in time from the last infusion of DARZALEX during induction to the first infusion of DARZALEX during consolidation was 3.75 months (range, 2.4-6.9).⁴
  • The first infusion of DARZALEX administered during consolidation was given at
    16 mg/kg IV of actual body weight every 2 weeks along with VTd.^2,3

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 06 May 2025.