According to a summary statement of opinion issued yesterday by the Committee for Medicinal Products for Human Use (CMPH) of the European Mediciens Agency (EMEA), CMPH is recommending an expanded indication for the clinical use of abiraterone acetate in men with metastatic, castration-resistant prostate cancer (mCRPC).
The summary statement of opinion states that abiraterone acetate (Zytiga®) will be indicated, in combination with predisone or prednisolone, for:
- The treatment of mCRPC in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated, and for
- The treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The latter of these two indications is the currently approved indication in Europe and the USA. The former is a new indication for earlier use in men who have received no chemotherapy, and is based on data from the second Phase III clinical trial of abiraterone acetate, presented at the annual meeting of the American Society for Clinical Oncology (ASCO) earlier this year.
The final decision of the European Commission to approve this new indication for Zytiga in Europe can be expected within about 60 days.
This decision to recommend and expanded indication for Zytiga in Europe suggests that we may see a similar expansion of the indication for Zytiga in the USA as well … perhaps by the end of the year.