EC opens up Xtandi use to non-metastatic group

The European Commission (EC) has followed in the footsteps of the US Food and Drug Administration (FDA) by approving Xtandi (enzalutamide) in men with high-risk, non-metastatic, castration-resistant prostate cancer (nmCRPC).

This means that in Europe, as in the USA, Xtandi is now approved in two indications, having earlier been given the green light for metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated or whose disease has progressed on or after docetaxel therapy.

The new approval is based on the Phase III PROSPER trial, which pitted the non-steroidal antiandrogen therapy plus androgen deprivation therapy (ADT) against placebo and ADT. The amount of people who developed metastatic prostate cancer or died was 23% for the Xtandi group, compared to 49% in the other arm.