US clears first ‘liv­ing drug’ for tough child­hood leukemia

The Oneida Daily Dispatch (Oneida, NY) - - Weather -

The Food and Drug Ad­min­is­tra­tion on Wed­nes­day ap­proved the first treat­ment that ge­net­i­cally en­gi­neers pa­tients’ own blood cells into an army of as­sas­sins to seek and de­stroy child­hood leukemia.

The CAR-T cell treat­ment de­vel­oped by No­var­tis Phar­ma­ceu­ti­cals and the Univer­sity of Penn­syl­va­nia is the first type of gene ther­apy on the U.S. market, and one in a pow­er­ful but ex­pen­sive wave of cus­tom-made “liv­ing drugs” be­ing tested against blood can­cers and other tu­mors, too. The FDA called the ap­proval his­toric.

“This is a brand new way of treat­ing can­cer,” said Dr. Stephan Grupp of Chil­dren’s Hospi­tal of Philadel­phia, who treated the first child with CART cell ther­apy, a girl near death but who now is can­cer-free for five years.

No­var­tis said it would charge $475,000 for the treat­ment, made from scratch for ev­ery pa­tient. But the com­pany said there would be no charge if the pa­tient didn’t show a re­sponse within a month.

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