European Commission expands license for Janssen's Zytiga
The European Commission has given its backing to broaden the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications.
The expanded approval was granted to Janssen-Cilag International, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ).
The European Commission has already approved the combination of Zytiga plus prednisone/prednisolone as treatment for adult men with mCRPC who have no or mild symptoms and failed to respond to ADT, and for whom chemotherapy is not indicated. The drug is also approved for adults whose disease has progressed or who received a Taxotere (docetaxel)-based chemotherapy regimen.
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