The U.S. Food and Drug Administration announced yesterday that it has formally agreed to expand the off-label use of Genentech's Herceptin breast cancer drug to include patients with early-stage breast cancer who have undergone surgery.
The FDA's decision to expand Herceptin prescribing practices was expected in August, but the agency requested more information prior to its decision. However, according to Citigroup analysts, doctors across the country were already extensively prescribing Herceptin to early-stage breast cancer patients before the FDA gave approval.
Herceptin first entered the market in 1998 as a treatment for the 25 to 30 percent of breast cancer patients whose tumors generate a protein called HER-2. The drug was recommended for patients whose cancer had spread beyond the breast. After Genentech announced last year that it had conducted a trial yielding positive results for the use of Herceptin in combination with chemotherapy in early-stage cancer patients, doctors began writing off-label prescriptions for the drug in such patients, prior to FDA approval.
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