FDA Approves New Multiple Myeloma Indications for Daratumumab and Hyaluronidase

Article

The subcuntaenous therapy's base drug was approval for two separate multiple myeloma indications last year.

FDA

The US Food and Drug Administration (FDA) has approved daratumumab and hyaluronidase (DARZAFLEX FASBRO) as a multiple-regimen subcutaneous formulation for the treatment of patients with multiple myeloma.

The approval granted to the Janssen Pharmaceutical drug approved the daratumumab formulation in 4 different regimens across 5 multiple myeloma indications—including newly diagnosed, transplant-ineligible patients, plus relapsed or refractory patients.

The new indications are supported by findings from the phase 3 COLUMBA study showing relapsed or refractory patients treated with therapy had a consistent overall response rate (ORR) and pharmacokinetics, as well as a similar safety profile, to intravenous daratumumab.

Patients treated with the subcutaneous formulation also reported a nearly two-thirds reduction in systemic administration-related reactions (34%) versus long intravenous daratumumab (13%).

The approval was also supported by the phase 2 PLEIADES trial, in which daratumumab and hyaluronidase showed efficacy and safety in combination with borteomib, melphalan, and prednisone (D-VMP) in newly diagnosed transplant-ineligible patients. Treated relapsed or refractory patients who received just one prior line of therapy also reported objective response with the formulation in combination with lenalidomide and dexamethasone (D-Rd).

Daratumumab combination regimen was previously approved by the FDA for the treatment of newly diagnosed, autologous stem cell transplant (ASCT)-eligible patients with multiple myeloma last September—and 3 months before, for patients ineligible for ASCT.

Mathai Mammen, MD, PhD, global head of Janssen Research & Development, said the approval is doubly beneficial for eligible patients, as the subcutaneous formula improves on intravenous daratumumab treatment time by hours—just 3-5 minutes.

“Based on its favorable profile, we are accelerating the development of DARZALEX FASBRO and evaluating its potential in multiple ongoing studies,” Mammen said in a statement.

Related Videos
How Gene and Cell Therapy Is Developing in Dermatology
Joyce Teng, MD, PhD, discusses how therapeutic advances in fields like epidermolysis bullosa should progress treatment discourse in other rare dermatoses.
The Prospect of Pz-cel in RDEB Treatment, with Peter Marinkovich, MD
Comparing New Therapies for Dystrophic Epidermolysis Bullosa
Reviewing 2023 with FDA Commissioner Robert M. Califf, MD
Dunia Hatabah, MD | Image Credit: HCPLive
Ricky Safer: What Clinicians Need to Know About PSC
Ryan T. Fischer, MD: Long-Term Odevixibat Benefit for Alagille Syndrome
Saeed Mohammad, MD: IBAT Inhibitors for Cholestatic Disease
Mercedes Martinez, MD: Treatment Strategies for Autoimmune Hepatitis
© 2024 MJH Life Sciences

All rights reserved.