FDA of­fers an­oth­er speedy can­cer drug OK, ap­prov­ing Jazz’s Vyx­eos for acute myeloid leukemia

In just the lat­est case of a can­cer drug sped along by the FDA, Jazz Phar­ma­ceu­ti­cals $JAZZ to­day won ap­proval for Vyx­eos (CPX-351) as a new ther­a­py for acute myeloid leukemia.

The FDA not on­ly pro­vid­ed a break­through ther­a­py des­ig­na­tion for the drug — a com­bi­na­tion of cy­tara­bine and daunoru­bicin — it al­so of­fered an ab­bre­vi­at­ed 6-month pri­or­i­ty re­view for the treat­ment.

“This is the first ap­proved treat­ment specif­i­cal­ly for pa­tients with cer­tain types of high-risk AML,” said Richard Paz­dur, di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence and act­ing di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s CDER. “Vyx­eos com­bines two com­mon­ly used chemother­a­pies in­to a sin­gle for­mu­la­tion that may help some pa­tients live longer than if they were to re­ceive the two ther­a­pies sep­a­rate­ly.”

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