Astellas received label extension approval of Xtandi as monothx or in combo with ADT to treat unsuitable salvage-radiotherapy, adult men with high-risk BCR nmHSPC
The approval was based on EMBARK (P-III) study (n=1,068). Xtandi (160 mg) in combo with leuprolide (n=355) reduced cancer spreading risk or death by 57.6% and Xtandi alone (160 mg) (n=355) reduced risk by 36.9% vs PBO with 22.5 mg leuprolide (n=358) at every 12wks. Study met its both 1EP (MFS) and 2EP (reduction in risk of metastasis or death)
Revised guidelines of EAU in Apr’24, recommends Xtandi in high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery; Xtandi is a novel hormone therapy approved for multiple indications in over 90 countries (incl. US, EU, and Japan)
Ref: Astellas | Image: Astellas
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