CHMP recommends approval of Nubeqa in non-metastatic castration-resistant prostate cancer.- Orion Corporation and Bayer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Nubeqa (darolutamide), from Orion Corporation and Bayer, an androgen receptor inhibitor (ARi), for marketing authorization in the European Union (EU). The compound is recommended for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The final decision of the European Commission on the marketing authorisation is expected in the coming months. The androgen receptor inhibitor (ARi) is already approved in the in the U.S., Brazil and Japan and filings in other regions are underway or planned by Bayer.The CHMP recommendation is based on the results of the Phase III ARAMIS trial evaluating darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT, which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median 40.4 months, versus 18.4 months for placebo plus ADT (p<0.0001), and a favorable safety profile. the most frequent adverse reactions in the darolutamide plus adt arm, that occurred with an absolute increase in frequency of="">2% compared to placebo plus ADT, were fatigue/asthenic conditions (16% vs. 11%), pain in extremity (6% vs. 3%), and rash (3% vs. 1%). Discontinuation due to adverse events occurred in 9% of patients in both arms of the study.