The U.S. Food and Drug Administration (FDA) has approved Darzalex (daratumumab), in combination with Kyprolis (carfilzomib) and dexamethasone, to treat adults with relapsed or refractory multiple myeloma after one to three lines of therapy. Specifically, Darzalex — created by Genmab, and developed and commercialized by Janssen Pharmaceuticals — was approved in combination with two dosing regimens of Kyprolis (developed by Amgen): 70 mg/m2 once weekly, and 56 mg/m2 twice weekly. The approval comes six months after Janssen submitted a supplemental biologics license application to extend…
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