Astellas wins approval in Japan for Claudin18.2 therapy after US rejection

Astel­las won ap­proval in Japan for Vy­loy, its gas­tric can­cer drug that was re­ject­ed by the FDA in Jan­u­ary over man­u­fac­tur­ing is­sues.

Vy­loy, al­so known as zol­be­tux­imab, tar­gets a pro­tein called Claudin18.2 (CLDN18.2) that’s ex­pressed on the sur­face of gas­tric can­cer cells. Oth­er drug­mak­ers are test­ing sim­i­lar ap­proach­es, in­clud­ing Leap Ther­a­peu­tics and As­traZeneca. But Astel­las said Tues­day that Vy­loy is the first of its class to re­ceive ap­proval world­wide.

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