FDA Approves Darzalex Faspro Plus Kyprolis and Dexamethasone for Myeloma Treatment

The Food and Drug Administration (FDA) has approved the regimen of Darzalex Faspro (daratumumab plus hyaluronidase-fijh) and Kyprolis (carfilzomib) plus the steroid dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who received one to three prior treatments, according to the FDA.

The approval is based off findings from a subgroup of patients in the PLEIADES clinical trial, which included 66 patients with relapsed/refractory myeloma who had at least one prior treatment and were given the three-drug combination. The main goal of the study was to assess the overall response rate (ORR), which is the percentage of patients whose disease responded to the treatment. Study findings showed that the ORR was 84.8%.

Researchers on the trial were also analyzing duration of response, though since many patients’ response lasted so long, an average duration of response was not yet available at the 9.2-month follow-up mark. It was estimated that 85.2% of patients had a response that lasted for at least six months, and 82.5% had a response that lasted at least nine months.

The most common side effects that occurred in at least 20% of the study population were: upper respiratory tract infections, fatigue, insomnia, high blood pressure, diarrhea, cough, difficulty breathing, headache, fever, nausea and edema peripheral (which is characterizedby swelling in the lower legs and hands).

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