FDA Approves Subcutaneous Daratumumab Triplet Combo for Relapsed/Refractory Multiple Myeloma

A combination of daratumumab, hyaluronidase-fihj, carfilzomib, and dexamethasone has been approved by the FDA for the treatment of relapsed/refractory multiple myeloma.

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

The addition of hyaluronidase allows for subcutaneous dosing of daratumumab.

The combination was evaluated as part of the phase 2 multicohort, open-label PLEIADES study (NCT03412565). Patients treated with 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 had not yet been reached, although 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.

Common adverse events included upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.


FDA approves Darzalex Faspro, Kyprolis, and dexamethasone for multiple myeloma. News release. FDA. November 30, 2021. Accessed December 1, 2021. https://bit.ly/31iz8EW