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UPDATE 1-FDA OKs expanded use of Glaxo breast cancer drug
January 29, 2010 / 11:37 PM / in 8 years

UPDATE 1-FDA OKs expanded use of Glaxo breast cancer drug

* Tykerb approved in combination with Femara

* For use in HER2-positive, hormone positive breast cancer

NEW YORK, Jan 29 (Reuters) - U.S. health regulators on Friday broadened the approval of GlaxoSmithKline’s (GSK.L) breast cancer drug Tykerb, saying it can now be used in combination with the Novartis NOVN.VX breast cancer drug Femara.

The Food and Drug Administration said the combination was approved to treat hormone positive and HER2-positive advanced breast cancer in post-menopausal women for whom hormonal therapy is indicated.

HER2 is a protein involved in normal cell growth that is found in some breast cancers. Certain medicines, such as Roche’s ROG.VX Herceptin, have been found to be effective only in women who have an excess of the HER2-protein.

In hormone positive breast cancer, the presence of certain hormones contributes to breast cancer growth.

Tykerb, a pill, works by depriving tumor cells of signals needed to grow and blocks the function of the HER2 protein.

It was initially approved for use in combination with the chemotherapy drug Xeloda for advanced breast cancer patients who had received prior treatment with other chemotherapy agents and Herceptin.

“This drug combination of Tykerb plus Femara provides women being treated for advanced breast cancer with an important treatment option,” Richard Pazdur, the FDA’s director of the Office of Oncology Drug Products, said in a statement.

The approval was based on a study in which patients who received the Tykerb/Femara combination went 35 weeks before their cancer progressed compared with 13 weeks for women who received Femara alone. (Reporting by Bill Berkrot)

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