Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
"I am pleased that the addition of subcutaneous daratumumab to KYPROLIS plus dexamethasone will offer increased flexibility and convenience for patients with relapsed or refractory multiple myeloma and will greatly reduce the administration burden," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
The expansion of the KYPROLIS prescribing information to include DARZALEX FASPRO plus dexamethasone was supported by the ongoing, Phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluating the clinical benefit of DARZALEX FASPRO administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma.
Updated data from the PLEIADES study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting, demonstrating that response rates with KYPROLIS in combination with DARZALEX FASPRO and dexamethasone were similar to those in the Phase 3 CANDOR study (KYPROLIS combined with intravenous [IV] DARZALEX and dexamethasone [DKd]), which supported the first-ever approval of an anti-CD38 monoclonal antibody in combination with KYPROLIS.1 The PLEIADES study met its primary endpoint, demonstrating an overall response rate of 84.8 percent with DARZALEX FASPRO-Kd.
"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 DKd treatment regimen will be a welcomed option for many of our patients," said Dr. Saad Usmani, M.D., chief of Myeloma Service at Memorial Sloan Kettering Cancer Center. "Administration time can be drastically reduced, as compared to the intravenous daratumumab formulation in combination with carfilzomib and dexamethasone."
Serious adverse reactions occurred in 27% of patients who received KYPROLIS in combination with DARZALEX FASPRO and dexamethasone. The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea and peripheral edema. Fatal adverse reactions occurred in 3% of patients.
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