FDA Approves Daratumumab and Hyaluronidase-fihj Plus Kd for Relapsed/Refractory MM

Daratumumab and hyaluronidase-fihj, in combination with carfilzomib and dexamethasone (Kd), has received U.S. Food and Drug Administration approval for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have previously received 1 to 3 lines of therapy.

This approval is based on updated data from the ongoing phase II PLEIADES study evaluating daratumumab and hyaluronidase-fihj plus Kd in patients with MM. At a median follow-up of 9.2 months, the overall response rate—the primary endpoint of the study—was 84.8%, with 77.3% of patients experiencing a very good partial response or better.

Common adverse events (AEs) occurring in at least 20% of patients treated with this combination were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema. Three patients died as a result of AEs.

Source: FDA.gov, December 1, 2021.