Afinitor receives EU recommendation to treat rare lung cancer

pharmafile | April 29, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Afinitor, Novartis 

Novartis has received a recommendation from the Committee for Medicinal Products for Human Use at the European Medicines Agency for rare lung cancer treatment, Afinitor (everolimus).

If approved by the European Commission, it will be the first treatment in the EU indicated for advanced progressive, non-functional neuroendocrine tumours of gastrointestinal or lung origin.

Alessandro Riva, global head of oncology at Novartis, says: “This important milestone reinforces our long-standing commitment to the NET community by providing solutions to help improve outcomes for patients with these rare and difficult-to-treat cancers.”

This recommendation is based on positive results from Phase III trials into the efficacy, quality and safety of Afinitor in the treatment of neuroendocrine tumours. These forms of tumours most commonly arise in the GI tract, lungs or pancreas. Progression, or continued growth or spread of the tumour, is typically associated with poor patient prognoses.

In the RADIANT-4 clinical trial, Afinitor reduced the risk of progression in patients with these tumours by 52% vs placebo.

The FDA approved the drug in February.

Sean Murray

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