Frequently Asked Questions
Here are some common questions and answers regarding treatment with DARZALEX FASPRO®and DARZALEX®.
Indications
DARZALEX FASPRO® is indicated for the treatment of adult patients with newly diagnosed multiple myeloma:
- Transplant eligible—in combination with VRd (induction and consolidation) and in combination with VTd1
- Transplant ineligible—in combination with Rd, VRd, or VMP1
DARZALEX® is indicated for the treatment of adult patients with newly diagnosed multiple myeloma:
- Transplant eligible–in combination with VTd2
- Transplant ineligible–in combination with Rd or VMP2
View the indications for DARZALEX FASPRO® and DARZALEX®
Visit NowRd=lenalidomide (R) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P); VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).
Review NCCN recommendations for daratumumab-containing regimens
Visit NowNCCN=National Comprehensive Cancer Network.
Dosing and administration
DARZALEX FASPRO® is the only anti-CD38 monoclonal antibody that can be delivered subcutaneously in ~3 to 5 minutes.1
Learn more about the administration of DARZALEX FASPRO®
Visit NowCD38=cluster of differentiation 38.
For adult patients who have newly diagnosed, transplant-ineligible multiple myeloma and are being treated with DRd, dosing frequency decreases to once every 4 weeks starting at Cycle 7.1,2
View dosing schedules for DARZALEX FASPRO® and DARZALEX®
Visit NowDRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d).
In the COLUMBA trial, nearly 3× reduction in systemic ARRs with DARZALEX FASPRO® (13%, n=260) vs DARZALEX® (34%, n=258) was observed.4
Both systemic ARRs, including severe or life-threatening reactions, and local injection-site reactions can occur with DARZALEX FASPRO®. Fatal reactions have been reported with daratumumab-containing products, including DARZALEX FASPRO®.1
View systemic ARR data
Visit NowARR=administration-related reaction.
Efficacy
The PERSEUS trial was a phase 3 open-label, randomized, active-controlled trial in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplant (ASCT) comparing DARZALEX FASPRO® + VRd (n=355) vs VRd (n=354) during induction and consolidation. The major efficacy outcome measure was progression-free survival (PFS) by Independent Review Committee (IRC) assessment based on International Myeloma Working Group (IMWG) response criteria. The median age was 60 years (range: 31-70).1,5
Following post-transplant consolidation, patients received investigational DR maintenance vs R alone. The trial was not designed to isolate the effect of DARZALEX FASPRO® in maintenance, and the efficacy of DR for maintenance has not been established.1
The primary efficacy endpoint was progression-free survival (PFS). The secondary endpoints were overall response rate (ORR) and minimal residual disease (MRD).5
DR=DARZALEX FASPRO® (D) + lenalidomide (R); R=lenalidomide; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
The efficacy of DVRd was evaluated in the PERSEUS trial, a phase 3 global, randomized, open-label trial comparing treatment with DVRd (n=355) to VRd (n=354) in adult patients with newly diagnosed, transplant-eligible multiple myeloma. In the trial, treatment was continued until disease progression or unacceptable toxicity.1,5
Following post-transplant consolidation, patients received investigational DR maintenance vs R alone. The trial was not designed to isolate the effect of DARZALEX FASPRO® in maintenance, and the efficacy of DR for maintenance has not been established.1
After 47.5 months of follow-up, there was a 60% reduction in the risk of disease progression or death with DVRd vs VRd alone (HR=0.40; 95% CI: 0.29-0.57; P<0.0001).1,5*†
View trial results
Visit NowCI=confidence interval; DR=DARZALEX FASPRO® (D) + lenalidomide (R); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; IRC=Independent Review Committee; IMWG=International Myeloma Working Group; NR=not reached; R=lenalidomide; VRd=bortezomib (V) + lenalidomide (R) + dexamethasone (d).
*Median follow-up was 47.5 months in the DVRd and VRd group (range: 0.0-54.4 months).5
†Progression-free survival was by IRC assessment based on IMWG criteria.1
The efficacy of DRd was evaluated in the MAIA trial, a phase 3 global, randomized, open-label trial comparing treatment with DRd (n=368) to Rd (n=369) in adult patients with newly diagnosed, transplant-ineligible multiple myeloma. In the trial, treatment was continued until disease progression or unacceptable toxicity.2
The primary efficacy endpoint was progression-free survival (PFS). One of the secondary endpoints was overall survival (OS).2
After 28 months of follow-up, there was a 44% reduction in the risk of disease progression or death with DRd vs Rd alone (HR=0.56; 95% CI: 0.43-0.73; P<0.0001).2
After 64 months of follow-up, median PFS was 61.9 months (95% CI: 54.8-NE) with DRd vs 34.4 months (95% CI: 29.6-39.2) with Rd (HR=0.55; 95% CI: 0.45-0.67).2
View trial results
Visit NowCI=confidence interval; DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; NE=not estimable; PFS=progression-free survival; Rd=lenalidomide (R) + dexamethasone (d).
In the MAIA trial, DRd was evaluated in a wide range of patients. About 44% of patients were 75 years of age or older and the trial included patients with various ECOG performance status, cytogenetic profiles, and ISS disease stages.2,6
See demographic information from the MAIA trial
Visit NowDRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); ECOG=Eastern Cooperative Oncology Group; ISS=International Staging System.
DRd is indicated for the treatment of newly diagnosed, transplant-ineligible multiple myeloma until progression or unacceptable toxicity. For the best chance of achieving the PFS and sustained responses seen in the MAIA trial, patients should be treated with DRd until progression or unacceptable toxicity.2
View PFS results
Visit NowDRd=DARZALEX®/DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); PFS=progression-free survival.
Coverage
DARZALEX FASPRO® and DARZALEX® are covered for ~97% of people with commercial insurance and ~97% of people with Medicare.7
This may not represent 100% of lives due to data limitations.
Mechanism of action
Daratumumab inhibits tumor cell growth through immune-mediated, direct on-tumor, and immunoregulatory actions. It may also have an effect on normal cells.1,2
Learn more about the mechanism of action
Visit NowPatient resources
There are a wide variety of resources available to help provide educational, emotional, and financial support to patients throughout their treatment.
Your patients have access to free 1-on-1 support from a dedicated Care Navigator* who can help them:
- Understand their disease and learn more about DARZALEX® or DARZALEX FASPRO®
- Find health and wellness resources for living with cancer
- Explore cost support options regardless of their insurance type
- Help them find online or in-person patient-to-patient support
- Connect them with transportation-related services in their community
Get started with J&J withMe
- Visit Portal.JNJwithMe.com to investigate insurance coverage for your patients, enroll your patients in savings, or sign them up for Care
Navigator support - Visit www.JNJwithMe.com/hcp/
darzalex for access and affordability information for DARZALEX® and DARZALEX FASPRO® - Questions? Call 833-JNJ-wMe1 (833-565-9631), Monday through Friday, 8:00 AM to 8:00 PM ET
View patient support resources
Visit Now*Care Navigators do not provide medical advice.
