Novartis has received the US Food and Drug Administration (FDA) approval for its Afinitor (everolimus) tablets for the treatment of progressive, non-functional gastrointestinal (GI) and lung neuroendocrine tumors (NET).
NETs 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.
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Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET.
The Afinitor tablets can be used to fulfil unmet needs as progressive, non-functional GI and lung NET are rare cancers with poor prognoses, limited treatment options.
Novartis oncology president Bruno Strigini said: “Afinitor is the first treatment approved for progressive, non-functional NET of lung origin, and one of very few options available for progressive, non-functional GI NET, representing a shift in the treatment paradigm for these cancers.
“We are proud of our Afinitor development programme, which has translated to meaningful benefits for patients with several different cancers and rare diseases.”
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By GlobalDataMore than 70% of patients with NET have non-functional tumours, which cause symptoms such as intestinal obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive pulmonary disease and pneumonia for lung NET.
The approval was based on the results of a pivotal study RADIANT-4 that showed Afinitor reduced the risk of progression in patients with progressive, well-differentiated, non-functional NET of GI or lung origin by 52% against placebo.
Afinitor is approved in 99 countries, including the US and throughout the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin.
Regulatory filings for the GI / lung indication are underway in countries across the world, with a decision in the EU anticipated later this year.
Image: Micrograph of a neuroendocrine tumour. Photo: courtesy of Nephron.
