European Medicines Agency approves new indication for everolimus
Everolimus approved for the treatment of postmenopausal women with HR positive, HER2 negative advanced breast cancer without symptomatic visceral disease, in combination with exemestane, after recurrence or progression to a non-steroidal aromatase inhibitor
- Date : 26 Jun 2012
- Topic : Breast cancer , Gastrointestinal cancers , Anticancer agents & Biologic therapy
On 21 June 2012, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product everolimus (Afintor). The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd. They may request a re examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
The CHMP adopted a new indication as follows: "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".
Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full indications for everolimus will be as follows:
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.
- 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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