The long awaited FDA approval of Zytiga (abiraterone acetate), a once-daily oral agent, for the treatment of castration-resistant, metastatic prostate cancer following docetaxel chemotherapy has happened! Malecare celebrates this approval as it celebrates the significant numbers of new drug approvals we have had over the last year and one half. The approval of Zytiga represents [...]
On March 10th (my birthday) Dendreon announced that it has obtained clearance of its new work stations from the FDA. The result of this clearance is the quadrupling the output from the New Jersey factory where it makes sipuleucel-T (Provenge). When Dendreon obtained FDA clearance in April of 2010, it had extremely limited manufacturing capabilities [...]
Increasingly it has become obvious to me and to many other individuals that our current drug approval and development process has a basic flaw. If you go to research conferences you quickly learn that there is probably no magic bullet to stop any type of cancer, including advanced prostate cancer. Current drug development focuses on [...]
As we all anxiously wait for the FDA to finally make a determination about the pending application for approval of the investigational androgen biosynthesis inhibitor abiraterone acetate more data rolls in showing that supports the need to have a speedy approval. A new study published March 1, 2011, out of Italy adds support to the [...]
It has been announced that the application for the FDA approval of abiraterone with prednisone has been submitted by Centocor Ortho Biotech Inc. As I have discussed in prior posts, abiraterone is an extraordinarily promising investigational drug designed to treat metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane. [...]
The investigational drug Abiraterone, designed for the treatment of men with advanced prostate cancer who have failed chemotherapy has not yet been approved by the FDA. Because of the extraordinarily positive results that were obtained on the phase III trials (which were stopped early because of these fantastic results) the pharmaceutical manufacturer of the drug [...]
Applications for the approval of Abiraterone Acetate (Abiraterone) have been submitted to both the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA). The applications are for the approval of Abiraterone with prednisone for the treatment of metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane. [...]
Bavarian Nordic A/S today announced that they have received a letter of concurrence from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 3 study required for product registration for its product candidate, PROSTVAC®, for the treatment of men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer [...]
Ortho Biotech & Development, a unit of Cougar Biotechnology, Inc. has unblinded their Phase 3 study of abiraterone acetate plus prednisone. In the trial the abiraterone was used for the treatment of men with metastatic advanced prostate cancer has progressed following treatment with one or two chemotherapy regimens at least one of which contained docetaxel. [...]
Hot off the press- The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis SA's new chemotherapy drug for advanced prostate cancer. The drug, Jevtana (cabazitaxe) extended by nearly 2-1/2 months the lives of men with prostate cancer tumors that resist standard treatment with hormones as well as chemotherapy. The drug will be used after [...]
