According to a media release issued by Johnson & Johnson, the U.S. Food and Drug Administration (FDA) has granted a priority review for the supplementary New Drug Application (sNDA) for use of abiraterone acetate (Zytiga®) in treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC).
A priority review like this normally implies that the FDA will render a decision about a drug application within 6 months from the time of acceptance of the sNDA. Since this sNDA was submitted in June 2012 by Janssen Research & Development, LLC (a division of Johnson & Johnson), we may reasonably expect a decision about approval of this drug in treatment of chemotherapy-naive mCRPC by very late this year or some time very early in 2013.
Abiraterone acetate was initially approved by the FDA in April 2011 (in combination with prednisone) — for the treatment of patients with mCRPC who had previously received chemotherapy containing docetaxel.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment
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Great! Now we need approval when experiencing CRPC/HRPC and metastases not yet apparent. I see this as the more appropriate time when abiraterone acetate/Zytiga (and MDV3100/enzalutamide as well) would serve an earlier, even better purpose.
Chuck:
We’ll need some data from a large Phase III trial in this patient population before that approval is available … and to date I have seen no sign of the initiation of such a trial (for abiraterone acetate or for enzalutamide). Given the relatively short patent life left for abiraterone acetate, I’d be surprised to see such a trial using this compound. This is a study that might take several years to reach maturation.
Any experience with these drugs following Provenge?
Jerry:
Clinical trials exploring the use of either abiraterone acetate or enzalutamide after treatment with and in conjunction with sipuleucel-T have only recently been initiated. I am not aware of any reported data on this experience to date, although there are certainly patients who have been treated with one or both of these drugs after prior treatment with sipuleucel-T.
OK. Well, I guess I’m a test case. I have a rapid PSA doubling time and am scheduled to start sipuleucel-T next week. I expect my PSA will keep on rising during the month’s treatment. I’ll then see what’s next, but I assume it will be abiraterone with enzalutamide in some combination.
I will report back in a couple of months with results.