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 …

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 …

Are prostate cancer drug approvals going to be affected by FDA shutdown?

The U.S. Food and Drug Administration (FDA) has clearly indicated that extension of the current “partial shutdown” of the government will, in the not too distant future, start to delay approvals of new drugs and diagnostics and new indications for currently marketed drugs. … 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 …

Prostate ablation using HIFU — the role of patient preference information

A newly published review by staff of the Center for Devices and Radiological Health (CDRH at the U.S. Food & Drug Administration (FD) addresses the potential role for patient preference information (PPI) in determining patient perceptions of the “value” of high-intensity focused ultrasound (HIFU) and similar techniques in the management of prostate cancer. … 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 …

Medicare to cover genetic/genomic testing in advanced cancers

In an important decision announced late on Friday last week, the Centers for Medicare & Medicaid Services (CMS) announced that it had agreed to cover costs associated with genetic/genomic testing for Medicare patients with many advanced forms of cancer. … READ MORE …