(By Balaseshan) Johnson & Johnson's (NYSE: JNJ) Janssen-Cilag International NV said its Zytiga drug has received positive option recommendation from a committee of European Union for the treatment of metastatic castration resistant prostate cancer before chemotherapy.
The Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Zytiga. Janssen anticipates receiving the regulatory decision from the Commission in early 2013.
The CHMP adopted a new indication: "Zytiga is indicated 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."
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The CHMP adopted a new contraindication: Severe hepatic impairment (Child-Pugh class C). 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 3 COU-AA-302 study2 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.
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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.
Metastatic castration-resistant prostate cancer occurs when cancer has metastasised (spread) beyond the prostate to other parts of the body and the disease progresses despite serum testosterone below castrate levels.
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