Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA® (abiraterone acetate) for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. If endorsed by the European Commission, the recommendation would expand the indication for ZYTIGA®, which is currently approved for use in combination with prednisone/prednisolone to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the Phase III COU-AA-302 study on which this CHMP recommendation is based after a pre-specified analysis found statistically significant differences in radiographic progression-free survival (rPFS) and a strong trend in overall survival (OS) favouring ZYTIGA®. Based on these results, the IDMC also recommended that patients in the control arm be offered treatment with ZYTIGA®. Patients in the ZYTIGA arm also demonstrated a statistically significant difference in all the secondary endpoints compared to the control arm.
The CHMP is the committee responsible for the scientific assessment of products seeking centralised marketing authorisation throughout the European Union. The CHMP's positive opinion is now referred for approval to the European Commission. Janssen anticipates receiving the regulatory decision from the Commission in early 2013.
Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East, Africa, commented, "This positive opinion brings us a step closer to being able to offer ZYTIGA® to advanced cancer patients earlier in the course of their disease and fills a previously unmet medical need. If approved, the expanded indication will provide a welcome new option for patients with castration-resistant prostate cancer. It could not only give men a chance of extended survival, but may also delay the need for chemotherapy and help to improve their quality of life."
Janssen-Cilag International NV