FDA Approves Regimen of Darzalex Faspro, Kyprolis, and Dexamethasone for Relapsed or Refractory Multiple Myeloma

On November 30, 2021, the FDA approved the combination of subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro; Janssen Biotech) plus carfilzomib (Kyprolis; Amgen) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received 1 to 3 previous lines of therapy.

“Managing and coping with relapsed disease is a particularly challenging time in a patient’s treatment journey and having the option of subcutaneous daratumumab as part of the [Darzalex, Kyprolis, and dexamethasone] treatment regimen will be a welcomed option for many of our patients,” said Saad Usmani, MD, MBA, FACP, Chief, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York City. “Administration time can be drastically reduced, as compared to the intravenous daratumumab formulation in combination with carfilzomib and dexamethasone” he added.

This approval was based on a single-arm cohort in a multicohort, open-label clinical trial. The cohort included 66 patients with relapsed or refractory multiple myeloma who received ≥1 previous lines of therapy. All patients received the combination of subcutaneous daratumumab and hyaluronidase plus carfilzomib and dexamethasone.

The main efficacy outcome measure was overall response rate, which was 84.8% (95% confidence interval, 73.9%-92.5%). At a median follow-up of 9.2 months, the median duration of response to the combination therapy had not been reached; an estimated 85.2% of the patients maintained their response for ≥6 months, and 82.5% of the patients maintained their response for ≥9 months.

The most common (≥20%) adverse reactions were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema.

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