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FDA Approves Kyprolis Combo Therapy for Relapsed/Refractory Multiple Myeloma

doi: 10.1097/01.COT.0000481885.61747.8e
FDA Updates
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The U.S. Food and Drug Administration has approved Kyprolis (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. And the FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

The FDA had previously approved Kyprolis to treat patients with multiple myeloma who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy (OT 8/25/12 issue). And the FDA had also approved another expanded indication for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy in 2015.

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Trial Data

Approval for the new indication is based on data from the Phase III head-to-head ENDEAVOR study of 929 patients with multiple myeloma whose disease had relapsed after at least one, but not more than three, prior therapeutic regimens. The data (which were presented at the American Society of Clinical Oncology Annual Meeting) showed that progression-free survival was nearly twice as long (18.7 months) for patients with relapsed multiple myeloma who were treated with Kyprolis and low-dose dexamethasone compared with patients treated with bortezomib and low-dose dexamethasone (9.4 months) (OT 7/25/15 issue).

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Adverse Reactions

The most common adverse reactions among the patients receiving Kyprolis were anemia, diarrhea, dyspnea, fatigue, insomnia, pyrexia, and thrombocytopenia. Serious adverse reactions among the patients receiving Kyprolis were hypertension, dyspnea, cardiac failure, acute renal failure, ischemic heart disease, and pulmonary hypertension.

Kyprolis is marketed by Onyx Pharmaceuticals, Inc.

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Clinical Quick Facts

Drug: Kyprolis (carfilzomib)

Approved Indication: Treatment in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy; and as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy

Serious Side Effects: Hypertension, dyspnea, cardiac failure, acute renal failure, ischemic heart disease, and pulmonary hypertension

Common Side Effects: Anemia, diarrhea, dyspnea, fatigue, insomnia, pyrexia, and thrombocytopenia

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