Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

Bayer Submits EU’s Marketing Authorization Application to EMA for Darolutamide

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

Click here to read full press release/ article | Ref: Zeiss | Image: EMA News