Federal health regulators say OSI Pharmaceutical's Tarceva slows the progression of lung cancer and extends patients' lives when used as a follow-up to chemotherapy.
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 who are responding to chemotherapy. It is currently approved as a secondary treatment for patients whose cancer has progressed after chemotherapy.
A company study of 889 patients showed Tarceva stopped cancer from progressing for about three months when taken immediately following chemotherapy.
According to documents posted online, the FDA's main issue with Tarceva "concerns other available treatment options."
The FDA on Wednesday will ask a panel of outside experts to compare Tarceva as a maintenance therapy to Tarceva or the chemotherapy drug Taxotere as a secondary therapy. Taxotere is marketed by Sanofi Aventis.
Both Tarceva and Taxotere extend lives about three months when given to patients who have seen their cancer progress after taking first-choice chemotherapies, according to the FDA.
The agency is weighing whether Tarceva as a maintenance therapy is better than using it or Taxotere only after initial chemotherapy has stopped working.
The FDA is not required to follow the advice of its outside experts, though it usually does.
Tarceva is a daily pill and is also marketed as a first-line treatment for pancreatic cancer.
The drug is made by Melville, N.Y.-based OSI and sold in partnership with Roche's South San Francisco-based unit Genentech.
Shares of OSI Pharmaceuticals Inc. added 80 cents, or 2.3 percent, to $35.55 in afternoon trading.