FDA Approves Daratumumab Triplet Combo for Relapsed/Refractory Multiple Myeloma

Officials with FDA have granted approval to a regimen of daratumumab with hyaluronidase (Darzalex Faspro), hyaluronidase-fihj, carfilzomib (Kyprolis), and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received 1 to 3 prior lines of therapy.

The combination was evaluated as part of PLEIADES, a phase 2 multicohort, open-label study (NCT03412565). This arm of the trial enrolled 66 patients with RRMM who received at least 1 prior line of therapy. Patients were administered Darzalex Faspro 1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously in combination with Kyprolis (20/70 mg/m2 once weekly regimen) and dexamethasone.

Patients administered the daratumumab combination achieved an overall response rate of 84.8% (95% CI, 73.9%-92.5%). After a median follow up of 9.2 months, the median duration of response was not yet reached; however, it was estimated that 85.2% of patients would maintain their response for 6 months and 82.5% would maintain a response for 9 months.

The recommended dosing for Darzalex Faspro is 1800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously once weekly from weeks 1-8, once every 2 weeks from weeks 9 to 24, and once every 4 weeks starting week 25 until disease progression or unacceptable toxicity.

The most common adverse events (≥20%) associated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.

Reference

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma. [news release]. FDA. November 30, 2021. Accessed December 2, 2021. https://bit.ly/31iz8EW.