Lung cancer drug

People with the most common form of lung cancer that has continued to progress despite using other medications have a new treatment option--a drug that received expedited, or "fast-track," review from the FDA during its development.

The drug, Tarceva (erlotinib), was approved in November 2004 for treating people with locally advanced or metastatic non-small cell lung cancer (NSCLC). The FDA reviewed the drug application under "rolling review" procedures that are available to new fast-track drug applications. In rolling review, the FDA starts reviewing specific parts of a drug approval application even before all the application information has been submitted to the agency.

In clinical trials, the drug has shown improved survival in people with NSCLC. The average survival time was about seven months for those taking Tarceva, compared with about five months in the group taking an inactive pill (placebo). The most common side effects reported in the trials were diarrhea, rash, nausea, and vomiting. Tarceva may cause fetal harm if taken by pregnant women.

Tarceva is manufactured by OSI Pharmaceuticals Inc. of Melville, N.Y., and distributed by Genentech Inc. of South San Francisco, Calif.