Land­mark Is­raeli Can­cer Treat­ment Ap­proved by FDA

The Jewish Voice - - HEALTH - By: Yona Sch­nitzer

Less than two months af­ter be­ing ac­quired by Phar­ma­ceu­ti­cal giant Gilead for $12B, Is­rael-based biotech com­pany Kite Pharma ob­tained US Food and Drug Ad­min­is­tra­tion (FDA) ap­proval for a can­cer treat­ment drug they have been de­vel­op­ing last Wed­nes­day.

The drug, called YESCARTA, is aimed at treat­ment of cer­tain types of blood can­cer called non-Hodgkin lym­phoma.

What Yescarta does is uti­lize white blood T-cells and ‘re­pro­grams’ them to fight can­cer cells. A sin­gle treat­ment with this drug will cost $373,000 in the US currency and spec­u­la­tion abounds that it could gen­er­ate hun­dreds of mil­lions in sales.

Ac­cord­ing to Reuters, and was re­ported by the JPost, the price of Yescarta is set be­low that of com­pa­ra­ble treat­ments, as No­var­tis AG’s gene ther­apy costs $475,000. The No­var­tis gene ther­apy, given the reg­u­la­tory nod in Au­gust, is ad­min­is­tered to at­tack child leukemia. The high price of the drugs, called CAR-Ts, may set off a de­bate about the bioeth­i­cal im­pli­ca­tions of making life-sav­ing phar­ma­ceu­ti­cals un­af­ford­able.

The JPost report also in­di­cated that “what dis­tin­guishes the Is­raeli-owned drug from other phar­ma­ceu­ti­cals is that each dose of­fers a per­son­al­ized treat­ment, made di­rectly from the pa­tient’s own im­mune sys­tem to fi ht the lym­phoma. Called im­munother­apy, the pa­tient’s in­fec­tion-fi ht­ing T-cells are ex­tracted and ge­net­i­cally en­gi­neered with a new gene to pin­point and kill the lym­phoma cells. Af­ter the cells are mod­i­fie , they are in­fused back into the pa­tient, where they patrol for years.”

“The FDA ap­proval of Yescarta is a land­mark for pa­tients with re­lapsed or re­frac­tory large B-cell lym­phoma. This ap­proval would not have been pos­si­ble without the coura­geous com­mit­ment of pa­tients and clin­i­cians, as well as the on­go­ing ded­i­ca­tion of Kite’s em­ploy­ees,” said Dr. Arie Bellde­grun, founder of Kite.

“To­day is an im­por­tant day for pa­tients with re­lapsed or re­frac­tory large B-cell lym­phoma who have run out of op­tions and have been wait­ing for new treat­ments that may help them in their fi ht against can­cer,” said John Mil­li­gan, Pres­i­dent and Chief Ex­ec­u­tive Offic of Gilead Sciences. “With the com­bined in­no­va­tion, talent and drive of the Kite and Gilead teams, we will rapidly ad­vance cell ther­apy re­search and aim to bring new op­tions to pa­tients with many other types of can­cer.”

“To­day marks an­other mile­stone in the de­vel­op­ment of a whole new sci­en­tific par­a­digm for the treat­ment of se­ri­ous dis­eases. In just sev­eral decades, gene ther­apy has gone from be­ing a promis­ing con­cept to a prac­ti­cal so­lu­tion to deadly and largely un­treat­able forms of can­cer,” said Food and Drug Ad­min­is­tra­tion Com­mis­sioner Scott Got­tlieb in a state­ment.

The treat­ment was fi st de­vel­oped at the Na­tional Can­cer In­sti­tute, led by Dr. Steven Rosen­berg, who signed an agree­ment with Kite Pharma in 2012. Kite helped fund the re­search process, in re­turn for re­ceiv­ing pa­tent roy­al­ties.

Ap­proval of the treat­ment has led to a four per­cent spike in Gilead stock.

“The FDA ap­proval of Yescarta is a land­mark for pa­tients with re­lapsed or re­frac­tory large B-cell lym­phoma,” said Dr. Arie Bellde­grun, founder of Is­rael­based Kite Pharma.

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