EMA Granted Extended Approval to Astellas’ XTANDI (Enzalutamide) for Recurrent Early Prostate Cancer Treatment
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
