Health Canada has recently approved an expanded use for enzalutamide (Xtandi) so that it can now be prescribed to treat men with non-metastatic castration-resistant prostate cancer (nmCRPC).
It has been announced that the Phase III ARAMIS Trial (Androgen Receptor inhibiting Agent for Metastatic-free Survival) evaluating an investigational treatment known as darolutamide in men with Non-metastatic Castration-resistant Prostate Cancer (nM0) has successfully met its primary endpoint of extending the metastasis-free survival (MFS) of men compared to placebo.
The FDA now will accept Metastasis-Free Survival (MFS) as a clinical trial endpoint for hormone sensitive cancer.
he FDA approved a new advanced hormone therapy drug (a next-generation androgen receptor inhibitor) for the treatment of men with non-metastatic castration-resistant prostate cancer (NM-CRPC). This drug with the trade name Erleada (aka apalutamide), is the first drug approved in this disease space.
An application has been made to the FDA for apalutamide, a possible hormonal treatment for men who are castrate resistant, but not yet metastatic.