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APPROVED

DARZALEX FASPRO® + VRd is approved in transplant-ineligible patients with newly diagnosed multiple myelomaNDMM1

DARZALEX FASPRO® monotherapy is the first and only FDA-approved treatment in high-risk smoldering multiple myeloma1DARZALEX FASPRO® monotherapy is now approved in high-risk smoldering multiple myeloma1

Dosing
(DARZALEX FASPRO®
+ VRd)

Dosing schedule for DARZALEX FASPRO® + VRd

Once-monthly dosing over time for patients with newly diagnosed, transplant-ineligible
multiple myeloma1

Dosing schedule with a DVRd regimen*

Reduce SubQ injection frequency to once monthly after only 6 months
of DARZALEX FASPRO® treatment

Dosing schedule with a DVRd regimen, graphicDosing schedule with a DVRd regimen, graphic

Continue DVRd until disease progression or unacceptable toxicity

Dosing schedule with a DVRd regimen

DARZALEX FASPRO® is the only anti-CD38 monoclonal antibody with ~3-5 minute administration§ approved for patients with NDMM1-3

CD38=cluster of differentiation 38; DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); NDMM=newly diagnosed multiple myeloma; SubQ=subcutaneous; VRd= bortezomib (V) + lenalidomide (R) + dexamethasone (d).

*The first dose of the every-3-week dosing schedule is given at Week 7. The first dose of the every-4-week dosing schedule is given at Week 25. See the Dosage and Administration section of the full Prescribing Information for more details. For dosing instructions of combination agents administered with DARZALEX FASPRO®, see Clinical Studies (14.1) section of the full Prescribing Information for DARZALEX FASPRO® and the respective manufacturer’s prescribing information.1

†Cycle=21 days.

‡Cycle=28 days.

§This refers to the injection administration time and does not account for all aspects of treatment.

References:

  1. DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. Sarclisa® (isatuximab-irfc) [Prescribing Information]. Bridgewater, NJ: Sanofi-Aventis US LLC.
  3. Ailawadhi S, Špička I, Spencer A, et al. Isatuximab subcutaneous by on-body injector versus isatuximab intravenous plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: phase III IRAKLIA study. J Clin Oncol. 2025;43(22):2527-2537.