A panel of the US Food and Drug Administration has been appointed to consider whether or not the popular cancer medicine Tarceva should be approved for wider and expanded use in patients who are suffering from advanced lung cancer.
Co-marketed by OSI Pharmaceuticals Inc. and Roche's Genentech division, Tarceva is, as of now, approved for treatment of non-small cell lung cancer, but only after a treatment with chemotherapy has failed to stop the disease's progress.
Currently, both the pharma companies are jointly looking for an FDA approval for administration of the drug immediately after chemotherapy "as a maintenance treatment in patients whose disease remained stable after chemotherapy".
The appointed FDA panel, which consists of various outside medical experts, is all set to meet on Wednesday and make recommendations about the granting wider use to the drug. According to the agency, both Tarceva and Docetaxel can "extend lives about three months when given to patients who have seen their cancer progress after taking first-choice chemotherapies. This raises the question whether treatment with single agent erlotinib (Tarceva) or Docetaxel after progression are better options than treatment with erlotinib as maintenance".
A daily pill, Tarceva is also marketed as a "first-line treatment" for pancreatic cancer.












