On November 30, 2021, the FDA approved the combination of subcutaneous Darzalex Faspro (daratumumab and hyaluronidase-fihj; from Janssen Biotech) plus Kyprolis (carfilzomib; from Amgen) and dexamethasone for the treatment of adults with relapsed (coming back) or refractory (not responding to therapy) multiple myeloma who have received 1 to 3 previous lines of therapy.
This approval was based on a single-arm cohort in a multicohort, open-label clinical trial of 66 patients with relapsed or refractory multiple myeloma who received 1 or more previous lines of therapy.
All patients received the combination of Darzalex Faspro, Kyprolis, and dexamethasone.
The overall response rate was 84.8% with this combination. At an average follow-up of 9.2 months, the average duration of response to the combination had not been reached (meaning many patients were still responding). An estimated 85.2% of the patients maintained their response for 6 months or longer, and 82.5% of the patients maintained their response for 9 months or longer.
The most common side effects with this combination were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema.