Posted on May 16, 2020 by Sitemaster
Yesterday evening the US Food and Drug Administration (FDA) approved rucaparib (Rubraca) for the treatment of men with BRCA1/2-mutant, metastatic, castration-resistant prostate cancer (mCRPC) who have also already been treated with androgen receptor-directed therapy and taxane-based chemotherapy. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: approval, castration-resistant, FDA, inhibitor, mCRPC, metastatic, PARP, Rubraca, rucaparib | 1 Comment »
Posted on September 18, 2019 by Sitemaster
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 …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: apalutamide, approval, Erleada, mCSPC, mHSPC, US | Leave a comment »
Posted on April 30, 2019 by Sitemaster
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: apalutamide, approval, castration-sensitive, mCSPC, metastatic, trial, TRITON | 3 Comments »
Posted on January 22, 2019 by Sitemaster
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 …
Filed under: Uncategorized | Tagged: approval, diagnostic, drug | Leave a comment »
Posted on January 17, 2019 by Sitemaster
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: apalutamide, approval, castration-resistant, Erleada, EU, Europe, nmCRPC, non-metastatic | 2 Comments »
Posted on August 13, 2018 by Sitemaster
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 …
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: approval, benefit, devices, FDA, HIFU, information, medical, patient, preference, risk | Leave a comment »
Posted on June 28, 2018 by Sitemaster
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 …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: approval, castration-resistant, indication, metastasis-free, non-metastatic, survival | 2 Comments »
Posted on March 26, 2018 by Sitemaster
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 …
Filed under: Diagnosis, Drugs in development, Living with Prostate Cancer, Management, Risk, Treatment | Tagged: approval, coverage, genetic, genomic, next generation, NGS, sequencing, test | 1 Comment »
Posted on February 15, 2018 by Sitemaster
Yesterday afternoon the US Food & Drug Administration (FDA) approved apalutamide — which will have the brand name Erleada — for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: apalutamide, approval, Erleada, SPARTAN | Leave a comment »
Posted on May 24, 2017 by Sitemaster
Yesterday, the US Food & Drug Administration (FDA) did something it has never done before. It approved a drug for the treatment of a type of cancer based exclusively on the presence of a specific biomarker — with no reference to the location of the cancer in the patient’s body. … READ MORE …
Filed under: Drugs in development | Tagged: approval, biomarker, FDA, pembrolizumab | 8 Comments »
Posted on February 3, 2016 by Sitemaster
For those able to access the February 2016 issue of the AUA News, it carries an interesting article outlining the U.S. Food and Drug Administration’s perspective on exactly why the agency decided to approve two forms of high-intensity focused ultrasound (HIFU) technology for the transrectal ablation of prostate tissue. … READ MORE …
Filed under: Management, Treatment | Tagged: approval, FDA, focuse, HIFU, high-intensity, ultrasound | 3 Comments »
Posted on December 4, 2015 by Sitemaster
As predicted, the U.S. Food and Drug Administration apparently approved the Ablatherm brand of equipment for high-intensity focused ultrasound (HIFU) on November 9 for “the ablation of prostate tissue.” … READ MORE …
Filed under: Uncategorized | Tagged: Ablatherm, approval, focused, HIFU, high-intensity, ultrasound | 2 Comments »
Posted on October 15, 2015 by Sitemaster
The U.S. Food & Drug Administration has now posted, on its web site, the approval letter issued to SonaCare Medical with reference to the approval to market the company’s Sonablate® 450 technology. … READ MORE …
Filed under: Treatment | Tagged: approval, FDA, HIFU, process, regulatory, Sonablate | 40 Comments »
Posted on October 12, 2015 by Sitemaster
Readers may wish to be aware that your sitemaster has been hearing whispers and rumblings that the U.S. Food and Drug Administration is either about to or has just approved some form of Sonacare Medical’s Sonablate high-intensity focal ultrasound (HIFU) techology for treatment of something related to the prostate. … READ MORE …
Filed under: Management, Treatment | Tagged: approval, focal, HIFU, high-intensity, ultrasound | 1 Comment »
Posted on December 2, 2014 by Sitemaster
The European Commission has expanded marketing authorization for enzalutamide to include treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically indicated. … READ MORE …
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: approval, enzalutamide, Europe | Leave a comment »
THE "NEW" PROSTATE CANCER INFOLINK 