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FDA Offers Full Approval for Amgen’s Blood Cancer Drug ‘Krypolis’

by Reshma Anand on Jan 23 2016 2:34 PM

Refractory myeloma may occur in patients who never see a response from their treatment or who initially respond to treatment, but stop responding after relapse.

FDA Offers Full Approval for Amgen’s Blood Cancer Drug ‘Krypolis’
The US food and Drug Administration has announced that it has approved Amgen’s supplemental new drug application for Kyprolis in combination with dexamethasone and Revlimid (lenalidomide) for the treatment of refractory multiple myeloma.
Krypolis can now be used for treating patients with relapse or refractory multiple myeloma who have received one to three treatment before.

The drug was approved as a single agent by the FDA in 2012 and now it has expanded it into full approval.

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.”

Source-Medindia


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