Novartis hails key regulatory decision for Afinitor
9 May 2011 00:00 in Pharmaceutical Company Product News
Novartis has hailed its success in obtaining US regulatory approval for Afinitor, its everolimus tablet-based treatment for advanced pancreatic neuroendocrine tumours.
The treatment has become the first product to be approved for this specification in the territory for nearly 30 years, with the company having also submitted a marketing application for the drug in this indication to the European Medicines Agency.
Authorisation was granted based on positive data from phase III clinical trials, showing Afinitor's efficacy in reducing tumour growth rates and cancer progression risk.
Everolimus is currently available in the EU under the trade name Certican for non-oncology applications, such as preventing organ rejection after heart and kidney transplants.
Herve Hoppenot, president of Novartis Oncology, said the new approval for the drug shows how effective treatments that target the protein mTOR to inhibit tumour growth can be.
This comes after the company launched Gilenya in the UK last month, with the product representing the first ever oral multiple sclerosis treatment released in Britain.
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