NOVEL CAN­CER TREAT­MENT WINS FDA EN­DORSE­MENT

The Denver Post - - NEWS -

Food and Drug Ad­min­is­tra­tion ad­vis­ers on Wed­nes­day en­thu­si­as­ti­cally en­dorsed a first-of-its-kind can­cer treat­ment that uses pa­tients’ revved-up im­mune cells to fight the dis­ease, con­clud­ing that the ther­apy’s ben­e­fits for des­per­ately ill chil­dren far out­weigh its po­ten­tially dan­ger­ous side ef­fects.

The unan­i­mous rec­om­men­da­tion from the On­co­logic Drugs Ad­vi­sory Com­mit­tee means the treat­ment could be ap­proved by the FDA by the end of Septem­ber.

Drug­maker No­var­tis is seek­ing ap­proval to use it for chil­dren and young adults whose leukemia doesn’t re­spond to tra­di­tional treat­ments — a group that num­bers 600 or so pa­tients a year in this coun­try. The ap­proach also is be­ing tested for a range of dis­eases, from non-Hodgkin lym­phoma and mul­ti­ple myeloma to solid tu­mors.

If cleared by the FDA, it would be the first gene ther­apy ap­proved in the United States. But un­like tra­di­tional gene ther­apy, the new treat­ment doesn’t re­place dis­ease­caus­ing genes with healthy ones. In­stead, it uses tech­nol­ogy to re­pro­gram im­mune cells called T cells to tar­get and at­tack ma­lig­nan­cies. — The Washington Post

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