Tykerb. FDA approved the extension of Tykerb indications

Feb.09, 2010

Tykerb

Tykerb

Tykerb

Food and Drug Administration USA (FDA) approved the extension of the indications for drug Tykerb (lapatinib). Tykerb is approved now as one of the most progressive drug in combination with letrozole for the treatment of hormone-receptor-positive metastatic breast cancer with overexpression HER2 after the menopause period.

FDA decision is based on the results of a double-blind, placebo-controlled study, in which were involved 219 women in the period after menopause with estrogen-receptor-positive metastatic breast cancer with overexpression of HER2. The study showed that the use of letrozole and lapainiba  leads to increasing of survivability by 5.2 months in comparison with letrozole monotherapy.

Approval of this combination can help women suffering from the disease to avoid the use  of severe cytotoxic chemotherapy.

Nearly 60% to 70% of all cases of breast cancer in Europe and the U.S. are estrogen-receptor-positive, and 25% to 30% – with the overexpression of HER2.

Tykerb has already been approved in combination with Xeloda (capecitabine) for the treatment of hormone-receptor-positive metastatic breast cancer with HER2 overexpression by patients who received anthracycline,  taxane and trastuzumab therapy.

Tykerb (lapatinib) is manufactured by pharmaceutical company GlaxoSmithKline.

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