FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma - PHARMA WISDOM

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Saturday 23 January 2016

FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma



The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's cancer drug Kyprolis in combination with certain other therapies to treat patients with multiple myeloma.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."
KYPROLIS:
The drug will be used in combination with dexamethasone or lenalidomide, plus dexamethasone, for relapsed or refractory multiple myeloma (MM) patients, who have received one to two therapies. 

Kyprolis is also approved as a single agent, for the same condition. The drug's mode of action is to prevent the breakdown of proteins in cancer cells, thereby killing them. The disease is incurable, but effective drugs can help manage the symptom profile.

MM is a fatal blood cancer that develops in the plasma cells, and matures in the bone marrow, a place where normal cells are formed. In a MM patient, abnormal plasma cells interfere with the growth and development of normal blood cells and kills.


Amgen said the agency approved Kyprolis in combination with dexamethasone or with the drug lenalidomide plus dexamethasone for relapsed or refractory patients. It approved the drug as a single agent for patients with relapsed or refractory disease who have received one or more treatments.

  



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