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Afinitor (everolimus)

Region

🇪🇺 EU

Active substance

everolimus

Company

Novartis Europharm Limited

Status

Authorised

Therapeutic area

Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms

EU approval

Sun 02 Aug 2009

Application

EMEA/H/C/001038

ATC

L01XE10

Official record

www.ema.europa.eu

Indication

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 post-menopausal 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.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Votubia Authorised · Novartis Europharm Limited

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.