Orion’s Darolutamide Receives EC’s Marketing Authorisation for the Treatment of Prostate Cancer
Shots:
- The EC has granted marketing authorization for darolutamide + ADT in combination with docetaxel to treat patients with mHSPC
- The approval was based on the P-III trial (ARASENS) evaluating darolutamide (600mg, BID) + ADT and docetaxel vs ADT + docetaxel in a ratio (1:1) in 1306 patients with mHSPC. Darolutamide is developed jointly by Orion and Bayer
- The results showed a 32.5% reduction in risk of death with consistent benefits across clinically relevant 2EPs, the overall incidence of TEAEs was similar b/w treatment arms. Darolutamide was approved under the brand name “Nubeqa” in 80+ countries globally incl. the US, EU, Japan & China for nmCRPC & was also approved for mHSPC in a no. of markets incl. the US & Japan
Ref: GlobalNewswire | Image: Orion
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