FDA Approves New Multiple Myeloma Indications for Daratumumab and Hyaluronidase

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


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.

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