FDA panel fa­vors new leukemia ther­apy

Northwest Arkansas Democrat-Gazette - - NATIONAL -

A panel of can­cer ex­perts Wed­nes­day rec­om­mended ap­proval of what could be­come the first gene ther­apy avail­able in the U.S.

The Food and Drug Ad­min­is­tra­tion ad­vi­sory panel voted 10-0 in fa­vor of an ad­vanced leukemia treat­ment de­vel­oped by the Univer­sity of Penn­syl­va­nia and No­var­tis Corp. The FDA usu­ally fol­lows rec­om­men­da­tions of its ex­pert pan­els but isn’t ob­li­gated to do so.

The ther­apy could be the first of a wave of treat­ments cus­tom-made to tar­get a pa­tient’s can­cer. Called CAR-T, it in­volves re­mov­ing im­mune cells from a pa­tient’s blood, re­pro­gram­ming them to cre­ate an army of cells that can zero in on and de­stroy can­cer cells, and in­ject­ing them back into the pa­tient.

“This is a ma­jor ad­vance,” said panel mem­ber Dr. Mal­colm Smith of the Na­tional Can­cer In­sti­tute. He said the treat­ment is “ush­er­ing in a new era.”

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