FDA approved Tarceva for treatment of locally advanced or metastatic non-small cell lung cancer, after failure of at least one prior chemotherapy regime in November 2004. OSI, the manufacturers of the drug had anticipated late January as the deadline for the approval, however FDA’s approval came well before in time, making it one of the fastest approvals ever. It approved in their “Pilot Program for Continuous Marketing Applications.” This pilot program was started keeping Tarceva like drugs in mind which demonstrated significant promise as a therapeutic advance over the conventional chemotherapy during the clinical trials, and hence given a Fast Track status.

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