(RTTNews) – Amgen (AMGN) said the United States Food and Drug Administration has approved the extension of the prescribing information for Kyprolis or carfilzomib in the United States 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 treatment.
The approval is supported by the ongoing, multi-center, non-randomized, open-label, multi-center PLEIADES trial evaluating the clinical benefit of Darzalex Faspro when administered in combination with four standard treatment regimens in patients with multiple myeloma. The study met its primary endpoint, demonstrating an overall response rate of 84.8% with Darzalex Faspro-Kd.
Amgen noted that serious side effects occurred in 27% of patients who received KYPROLIS in combination with DARZALEX FASPRO and dexamethasone. The most common side effects (= 20%) were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, fever, nausea and peripheral edema. Fatal side effects occurred in 3% of patients.
Amgen has said it will be submitting marketing applications globally.
Darzalex Faspro and Darzalex are registered trademarks of Johnson & Johnson.
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