ZYTIGA, the prostate cancer treatment drug developed by specialist healthcare company BTG, has been approved by the European Medicines Agency (EMA), the firm announced on Tuesday morning.
BTG, which develops and commercialises pharmaceutical products, highlighted the announcement by pharmaceuticals group Janssen-Cilag International that the Committee for Medial Products for Human Use (CHMP) of the EMA has "granted a positive opinion recommending approval" of ZYTIGA.
ZYTIGA, otherwise known as abiraterone acetate, is the oral, once-daily medication for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
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"If endorsed by the European Commission, the recommendation would expand the indication for ZYTIGA, which is currently approved for use in combination withprednisone/prednisolone to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen."
Janssen expects to receive the regulatory decision from the European Commission in early 2013.
"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," said Jane Griffiths, the Chairman of Janssen's Middle-East and African division.
"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."
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