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NEW INDICATIONS

Darzalex Faspro, Kyprolis, and Dexamethasone a New Combination FDA Approved for Multiple Myeloma

JHOP - December 2021 Vol 11, No 6 - FDA Oncology Update
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On November 30, 2021, the FDA approved the combination of subcutaneous (SC) 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.

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

The main efficacy 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%) side effects with this combination were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and peripheral edema.

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