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Comparable Overseas Reports (COR-A) pathway - First registration decision
Cabozantinib (CABOMETYX) is the first medicine to be registered on the Australian Register of Therapeutic Goods (ARTG) via the TGA's new COR-A pathway, which came into effect in January 2018.
The application relates to an extension of the available indications to include first line treatment of adults with poor or intermediate risk of advanced renal cell carcinoma (RCC). The extension of indication was registered on the ARTG on 1 November 2018 following approval by EMA on 8 May 2018.