FDA Approves Daratumumab Combination Therapy for Multiple Myeloma
Posted: Tuesday, December 7, 2021
On November 30, the U.S. Food and Drug Administration (FDA) approved the use of daratumumab and hyaluronidase-fihj (Darzalex Faspro) plus carfilzomib (Kyprolis) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who had one to three prior lines of therapy.
The recommended dose is 1,800 mg/30,000 units (1,800 mg of daratumumab and 30,000 units of hyaluronidase) administered subcutaneously once weekly at weeks 1 to 8, once every 2 weeks from weeks 9 to 24, and once every 4 weeks starting week 25 until disease progression or unacceptable toxicity. For full prescribing information, visit the FDA’s site for daratumumab and hyaluronidase-fihj and carfilzomib.
The FDA approval is based on the efficacy results from the multicohort, open-label PLEIADES clinical trial. The study recruited 66 patients with relapsed or refractory multiple myeloma who had at least one prior line of therapy. Patients were given subcutaneous doses consisting of 1,800 mg of daratumumab/30,000 units of hyaluronidase in combination with carfilzomib (20/70 mg/m2 once weekly regimen) and dexamethasone.
The overall response rate was 84.8%. The median duration of response was not reached after a median follow-up of 9.2 months. The estimated median duration of response was 85.2%, which was maintained for at least 6 months. Additionally, about 82.5% of patients maintained a response for at least 9 months.
The most common adverse reactions occurring in 20% or more of patients given the combination regimen included upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema.