FDA approves darolutamide for treatment of nmCRPC

Bayer’s US pharmaceutical division has announced that the US Food and Drug Administration (FDA) has approved darolutamide — their formerly investigational androgen receptor inhibitor — for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

ARCHES study data reported in JCO, and related issues

The initial data from the ARCHES study of standard ADT + enzalutamide versus standard ADT + a placebo in men with metastatic, hormone-sensitive prostate cancer were reported earlier this year at the Genitourinary Cancers Symposium in San Francisco. … READ MORE …

Darolutamide (ODM-201) in the treatment of nmCRPC

Earlier this year we had reported on the initial presentation of data demonstrating the efficacy and safety of darolutamide (formerly known as ODM-201), a third “super-antiandrogen” — similar to enzalutamide (Xtandi) and apalutamide (Erleada), in the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

Darolutamide (ODM-201) in the treatment of nmCRPC

Also on Thursday in San Francisco, Dr. Karim Fizazi presented the initial results from the ARAMIS trial of darolutamide (formerly known as ODM-201) in the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

ODM-201 meets Phase III goal in treatment of nmCRPC

Like other, similar drugs before it, ODM-201 — now properly known by the generic name darolutamide — has apparently hit the primary goal of metastasis-free survival in the Phase III ARAMIS trial, as announced yesterday by Bayer and Orion. … READ MORE …