EMA Adopts a New Indication for Everolimus

Everolimus is indicated for unresectable or metastatic, well-differentiated non-functional neuroendocrine tumours of gastrointestinal or lung origin

On 28 April 2016, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product everolimus (Afinitor). The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted a new indication as follows:

"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".

For information, the full indications for Afinitor 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 nonsteroidal 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."

Detailed recommendations 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 a decision on this change to the marketing authorisation has been granted by the European Commission.