* Tykerb approved in combination with Femara
* For use in HER2-positive, hormone positive breast cancer
NEW YORK Jan 29 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
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
"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)