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VIEW ALL NEWSU.S. approves Novartis' Afinitor for kidney cancer
DUBAI (Reuters) - U.S. regulators have approved Novartis AG's Afinitor drug for use in advanced kidney cancer and the Swiss group expects it to be effective against other disease types.
The U.S. Food and Drug Administration had requested more data on the once-a-day pill in November, effectively delaying its approval by three months, but now has given it the green light, Novartis said in a statement on Monday.
"Afinitor is a drug that really has the potential to treat many different cancers," said Joe Jimenez, head of Novartis pharmaceuticals business, who spoke by phone to Reuters ahead of the U.S. decision.
The FDA green light clears Afinitor for use in patients who have failed to respond to treatment with Sutent or Nexavar.
Afinitor works by blocking a protein known as mTOR and disrupting the growth, division and metabolism of cancer cells. Novartis is keen to expand its use into other types of cancer and expects to file for use in neuroendocrine tumours within the next year.
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