FDA label update for Kyprolis + dexamethasone for multiple myeloma.- Amgen
The FDA has added more data to the indication of Kyprolis with dexamethasone �specifically, data that showed Kyprolis from Amgen,, is superior to standard Velcade (bortezomib) in multiple myeloma. In the ENDEAVOUR trial, Kyprolis showed it could reduce the risk of death by 21% and increase overall survival by 7.6 months when compared with Velcade plus with dexamethasone.
The label update supports the Kyprolis-dexamethasone combination as the only preferred two-drug regimen recommended by the National Comprehensive Cancer Network Clinical Practice Guidelines for relapsed multiple myeloma patients.
"Blood cancer therapies approved by the FDA between 2003 and 2013 only improved overall survival by an average of 2.61 months,� according to David Reese, Amgen�s SVP of translational sciences and oncology adding that Kyprolis� 7.6 month advantage underscores �that this regimen is a significant advancement and should be considered a standard of care for patients with relapsed or refractory multiple myeloma."
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