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Published on 15 January 2013

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ZYTIGA® approved in the EU

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Janssen-Cilag International NV (Janssen) has announced that the European Commission (EC) has approved an extension to the license of the oral, once-daily medication ZYTIGA® (abiraterone acetate). The approved broader indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.(1)
Until now, ZYTIGA with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel- based chemotherapy regimen. This latest approval means that eligible men will potentially be able to benefit from treatment with ZYTIGA® earlier in the treatment pathway.
The EC’s decision follows recommendations from the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency(2) that were based on data from the Phase III COU-AA-302 study.(3) This was the first randomised study to demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in this patient population.
Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented, “This decision by the European Commission is hugely welcomed news. It marks another important step forward in the treatment of men with advanced castration-resistant prostate cancer. Treating men with ZYTIGA before they undergo chemotherapy has been shown to improve outcomes in many patients, both in terms of extending survival and in bettering quality of life. The fact that ZYTIGA’s licence has now been extended to include this indication will help fill a critical medical need and, we hope, serve to significantly improve the lives of many men across Europe suffering from this disease.”
References
  1. http://ec.europa.eu/health/documents/community-register/html/newproc.htm#h [last accessed January 2013]
  2. http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/002321/ WC500134841.pdf [last accessed January 2013]
  3. Ryan C.J et al. Interim analysis (IA) results of COU-AA-302, a randomized, phase III study of abiraterone acetate (AA) in chemotherapy-naive patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). J Clin Oncol 30, 2012 (suppl; abstr LBA4518)


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