FDA Approves New Multiple Myeloma Indications for Daratumumab and Hyaluronidase

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.