Lutetium-177 PSMA-617 in Phase III (VISION) trial for treatment of mCRPC

We have just been appraised of a randomized, double-blind, multi-center, Phase III clinical trial of the targeted, radiolabeled agent 177Lu-PSMA-617 (a form of “radioligand” therapy) in the treatment of metastatic, castration-resistant prostate cancer (mCRPC). … 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 …

I-131-MIP-1095 to enter randomized, Phase II clinical trial

As we reported last year, a new radiopharmaceutical has entered the pack. … READ MORE …

Ac-225-PSMA-617: another update

One of the more exciting new developments in radiopharmaceuticals for metastatic prostate cancer has been the development of alpha-particle emitters attached to PSMA ligands. We previously reported this update. … READ MORE …

Evolution in the management of nmCRPC

With the relatively recent approvals of apalutamide (Erleada) and enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), we are seeing intense discussion within the urologic oncology and medical oncology communities about the appropriate treatment of patients with this category of prostate cancer. … READ MORE …

FDA approves use of enzalutamide (Xtandi) for nmCRPC

As we predicted just a couple of weeks ago, on Friday the US Food and Drug Administration (FDA) approved the use of enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), … READ MORE …

MFS as a new endpoint in prostate cancer drug development

An article by staff at the U.S. Food and Drug Administration (FDA) in this week’s New England Journal of Medicine (NEJM) addresses the use of metastasis-free survival (MFS) as the primary endpoint in the trial that led to approval of apalutamide (Erleada) earlier this year. … READ MORE …