FDA approves GlaxoSmithKline's Tykerb

The FDA approved breast cancer drug Tykerb (lapatinib), GlaxoSmithKline stated Tuesday. The drugmaker anticipates that the treatment will be made available within the next two weeks.

Tykerb is indicated in the US to treat advanced or metastatic HER2-positive breast cancer, in combination with Roche's Xeloda in patients who have received prior therapy including an anthracycline, a taxane and Roche's and Genentech's Herceptin. The company noted that the drug is the first targeted, once-daily oral compound approved for this patient population in the country.

The FDA approval was based on findings from a late-stage trial involving 399 patients with advanced HER2-positive breast cancer who had received prior therapy. The results showed that the median time to disease progression was 27.1 weeks for patients who received Tykerb plus Xeloda, compared to 18.6 weeks in the group that received Xeloda alone.

Analysts anticipate that the drug could eventually record annual sales of as much as $4 billion, depending on whether it is approved for additional indications. Tykerb has also been filed with EU regulators and a decision is expected mid-year.

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