FDA Approves Once-Weekly Carfilzomib Combo for Relapsed or Refractory MM

The FDA has approved a combination of once-weekly carfilzomib with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma (MM). This is the third approved indication for the proteasome inhibitor carfilzomib, which previously received approval as a single agent and in combination with dexamethasone or with dexamethasone plus lenalidomide in this patient population.

The agency’s approval is based on results from the randomized phase III ARROW trial, which included 478 patients with relapsed or refractory MM who had received two or three prior therapies. Participants were randomly assigned to receive either a 30-minute infusion of once-weekly carfilzomib 70 mg/m2 with dexamethasone or a 10-minute infusion of twice-weekly carfilzomib 27 mg/m2 with dexamethasone.

Patients receiving the once-weekly treatment had longer progression-free survival compared with the twice-weekly cohort (11.2 months vs. 7.6 months, respectively; p=0.0014). The overall response rates were 62.9 percent and 40.8 percent in the once-weekly and twice-weekly arms, respectively (p<0.0001).

The most common adverse events in either arm of the ARROW trial were anemia, diarrhea, fatigue, hypertension, insomnia, and pyrexia.

Source: Amgen press release, October 1, 2018.