Cabozantinib

Renal cell carcinoma (RCC) CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma - as first-line treatment of adult patients with intermediate or poor risk (see section 5.1), - in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1). CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). Hepatocellular carcinoma (HCC) CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. Differentiated thyroid carcinoma (DTC) CABOMETYX is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy. Neuroendocrine Tumours (NET) CABOMETYX is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.

COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom rearranged during transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in section 5.1).