FDA approves new indication for Novartis’ Afinitor
pharmafile | February 29, 2016 | News story | Research and Development, Sales and Marketing | Afinitor, Novartis
Novartis’ cancer drug Afinitor (everolimus) has been granted FDA approval in a new indication: for the treatment of adult patients with nonfunctional, unresectable, locally advanced or metastatic neuroendocrine tumours of gastrointestinal or lung origin.
Afinitor had been granted a priority review in this indication, meaning a faster route through regulatory pathways, in clinical areas where there is unmet medical need and when the new drug offers an improvement over currently-available treatments.
“Afinitor is the first treatment approved for progressive, nonfunctional NET of lung origin, and one of very few options available for progressive, nonfunctional GI NET, representing a shift in the treatment paradigm for these cancers,” says Bruno Strigini, president, Novartis Oncology. “We are proud of our Afinitor development program, which has translated to meaningful benefits for patients with several different cancers and rare diseases.”
Neuroendocrine tumours (NET) are a rare type of cancer that originate in neuroendocrine cells throughout the body, and are most often found in the GI tract, lungs or pancreas. NET can be defined as functional or nonfunctional. The functional kind are caused by the oversecretion of hormones and other substances, while nonfunctional NET’s symptoms are caused by tumour growth. The latter accounts for more than 70% of cases.
Afinitor was approved in this new indication based on trial data showing the drug reduced the risk of progression by 52% compared with placebo, and also increased median progression-free survival (PFS) by 7.1 months: to 11.0 months.
Novartis says it has filed with regulators worldwide for approval in this indication, and that it expects a decision from the European Commission this year.
Joel Levy
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