Shots:

• The MAA submission is based on P-III ARAMIS study assessing Darolutamide + ADT vs PBO + ADT in 1-509 men with non-metastatic castration-resistant prostate cancer (nmCRPC) in ratio 2:1
• The P-III ARAMIS study demonstrated improvement in metastasis-free survival (mFS)- presented at ASCO GU in San Francisco with NDA filing & application for marketing in US FDA & MHLW- JAPAN respectively
• Darolutamide (600mg- q2d) is an androgen receptor antagonist- inhibits the growth of growth of prostate cancer cells- with low BBB penetration. Darolutamide is also evaluated in P-III ARASENS study for m-hormone-sensitive prostate cancer

Ref: Zeiss | Image: EMA News