Data from EMA (European Medicines Agency) - Curated by Toby Galbraith - Last updated 13 September 2017

Indication(s)

Hormone receptor-positive advanced breast cancer

Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

Neuroendocrine tumours of pancreatic origin
Afinitor is indicated for the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

Neuroendocrine tumours of gastrointestinal or lung origin
Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Renal cell carcinoma
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

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More information

Category Value
Agency product number EMEA/H/C/001038
Orphan designation No
Date First Approved 03-08-2009
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Novartis Europharm Ltd.