FDA “fast tracks” ARV-110 for the treatment of mCRPC

At the end of May, just prior to the annual meeting of ASCO, the US Food and Drug Administration (FDA) granted fast track designation to an investigational  agent called ARV-110 for treatment of metastatic, castration-resistant prostate cancer (mCRPC). … -READ MORE …

Phase III trial of olaparib in first-line treatment of mCRPC

Unfortunately we don’t always hear about some interesting clinical trials as early as we would like to. The following is a case in point. … READ MORE …

The treatment of mCRPC with a combination of docetaxel + enzalutamide

We know that both abiraterone acetate (Zytiga) and enzalutamide (Xtandi) can be used to extend the survival of men with mCRPC who have already been treated with docetaxel + prednisone. However, … 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 …

Apalutamide (Erleada) approved in EU for treatment of nmCRPC

Yesterday, Janssen Pharmaceuticals announced the approval of apalutamide (Erleada) by the European Commission (EC) for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC) who are at high risk for development of metastatic disease. … READ MORE …

Race and survival of men after docetaxel-based treatment for mCRPC

A new paper in the Journal of Clinical Oncology has just reported that the overall survival (OS) of black and white men diagnosed with metastatic castration-resistant prostate cancer (mCRPC) seems to be near to identical after treatment with docetaxel or a docetaxel-containing regimen. … READ MORE …

Survival of men with metastatic, castration-resistant prostate cancer

There has been regular discussion here and elsewhere about the degree to which new forms of therapy have impacted patient survival since the original approval of docetaxel for treatment of metastatic, castration-resistant  prostate cancer (mCRPC). … READ MORE …

Is there a subset of CRPC patients who may respond well to checkpoint inhibition?

A paper in the journal Oncotarget has suggested that patients who have progressed on treatment with enzalutamide (Xtandi) may be good candidates for treatment with one of the checkpoint inhibitors like pembrolizumab (Keytruda), nivolumab (Opdivo), or even ipilimumab (Yervoy). … READ MORE …

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 …