At its November 2025 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended granting marketing authorization in the EU for Enzalutamide Accordpharma (Accord Healthcare) for the treatment of prostate cancer. 

Enzalutamide Accordpharma is a generic and hybrid of Xtandi (enzalutamide, Astellas Pharma). The active substance is enzalutamide, a hormone antagonist that blocks several steps in the androgen receptor-signaling pathway. Xtandi has been authorized in the EU since 2013. 

The EMA said that the medicine was submitted in a hybrid application, which relied in part on the results of preclinical tests and clinical trials of the already authorized reference product and in part on new data.

Increased Survival

Worldwide, prostate cancer is the fourth most common cancer and the second most common cancer in men.

The EMA said that studies had demonstrated the satisfactory quality of Enzalutamide Accordpharma and its bioequivalence to the reference product Xtandi. 

Previous pivotal trials included the AFFIRM and the PREVAIL studies. In the AFFIRM study, the median overall survival for those receiving enzalutamide was 18.4 months compared with 13.6 months for those in the placebo group. In the PREVAIL study, the rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide, compared with 14% among those receiving placebo. There was also a 29% reduction in the risk for death for those who received enzalutamide compared with those who received placebo.

Enzalutamide Accordpharma is indicated:

• As monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent nonmetastatic hormone-sensitive prostate cancer who are unsuitable for salvage radiotherapy
• In combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer
• For the treatment of adult men with high-risk nonmetastatic castration-resistant prostate cancer
• For the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• For the treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy

Enzalutamide Accordpharma will be available as 40-mg, 80-mg, and 160-mg film-coated tablets. 

Rob Hicks is a retired National Health Service doctor. A well-known TV and radio broadcaster, he has written several books and has regularly contributed to national newspapers, magazines, and online publications. He is based in the United Kingdom.