The US Food and Drug Administration (FDA) has granted approval for Amgens’ Kyprolis (carfilzomib) combination therapy to treat patients with relapsed or refractory multiple myeloma.
Amgen has received approval for Kyprolis in combination with dexamethasone or with lenalidomide plus dexamethasone to treat patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
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Kyprolis has been approved by FDA as a single agent to treat patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Amgen research and development executive vice president Dr Sean Harper said: "Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs.
"Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer."
The FDA’s approval was based on results from the Phase III head-to-head Endeavor study, which demonstrated enhanced progression-free survival (PFS) with Kyprolis and dexamethasone compared to Velcade (bortezomib) and dexamethasone.
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By GlobalDataLast July, the FDA also approved another expanded indication for Kyprolis in combination with lenalidomide and dexamethasone (KRd) to treat patients with multiple myeloma who have received one to three prior lines of therapy.
Kyprolis is a product of Onyx Pharmaceuticals, which is a subsidiary of Amgen.
Image: Histopathological image of multiple myeloma. Photo: courtesy of KGH.
