FDA approves apalutamide for treatment of mCSPC here in US

Yesterday (September 17, 2019), the US Food and Drug Administration approved apalutamide (Erleada) for treatment of men with metastatic castration-sensitive prostate cancer (mCSPC) … 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 …

Full results of apalutamide in treatment of mHSPC

At the end of January, we had reported that the results of the TITAN trial — the Phase III trial of standard ADT + apalutamide (Erlead) or standard ADT + a placebo in men with metastatic, hormone-sensitive prostate cancer (mHSPC) — were positive, and that they were going to be reported at a meeting later in the year. … READ MORE …

J&J to seek approval of apalutamide in treatment of mCSPC

According to a media release issued yesterday by Johnson & Johnson, its Janssen Pharmaceuticals division has just submitted an application to the U.S. Food and Drug Administration for the approval of apalutamide (Eleada) in the treatment of men with metastatic, castration-sensitive prostate cancer (mCSPC). … READ MORE …

Positive outcomes for apalutamide in the treatment of mHSPC

According to a media release issued late yesterday by Johnson & Johnson, the combination of apalutamide (Erleada) + androgen deprivation therapy (ADT) has met the primary study endpoints in the so-called TITAN trial. … 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 …

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 …