Federal regulators said OSI Pharmaceuticals Inc.’s Tarceva slows the progression of lung cancer and extends patients’ lives when it follows chemotherapy.
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The Food and Drug Administration on Monday posted its review of the drug for a new use against lung cancer.
OSI wants the FDA to approve Tarceva as a maintenance therapy, or a drug designed to stop cancer from spreading in patients responding to chemotherapy. It is approved as a secondary treatment for patients whose cancer has progressed after chemotherapy.
A study of 889 patients showed Tarceva stopped cancer from progressing for about three months when taken immediately following chemotherapy.
Tarceva is a daily pill and is marketed as a first-line treatment for pancreatic cancer.