After a careful review of the (hundreds of) e-mails that accumulated in the several in-boxes used by the Sitemaster while he was on vacation, we are pleased to see that we appear to have missed just one really important new piece of ”news” about prostate cancer while we were off line.
On July 15, Johnson & Johnson announced that two of its operating companies had filed supplementary applications with the U.S. Food & Drug Administration (FDA) and with the European Medicines Agency (EMEA) seeking approval for the company to market abiraterone acetate (Zytiga) — in combination with prednisone or prednisolone — for the treatment of men with asymptomatic or mildly sympromatic, chemotherapy-naive, metastatic, castration-resistant prostate cancer, based on the results of the so-called “302 trial” – data from which was recently presented at the annual meeting of ASCO.
Here is the link to the media release issued by Johnson & Johnson’s relevant operating companies.
Assuming that these applications are “clean” and do not raise major questions for either the FDA or EMEA, one could reasonably expect to see approvals of abiraterone acetate for these indications in the USA and in Europe by the end of 2012. However, such approvals may take longer if either regulatory agency expresses concerns about the quality of the applications. As we have mentioned in prior commentary, there is the potential for such concerns on the part of the regulatory agencies.