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Glaxo pill for breast cancer OKd

March 14, 2007|From Reuters

WASHINGTON — GlaxoSmithKline won U.S. approval Tuesday for a once-a-day breast cancer pill that the drug maker hopes will launch a new era for its oncology business.

The Food and Drug Administration cleared the drug, called Tykerb, for patients with advanced breast cancer in combination with Roche Holding's oral chemotherapy drug, Xeloda, or capecitabine.

It is the first of four cancer drugs that Glaxo hopes to have approved by 2010. Studies of Tykerb, or lapatinib, to treat early-stage and inflammatory breast cancers, as well as head/neck, gastric and lung cancers, also are underway.

The FDA approved Tykerb for patients with HER-2 positive breast cancer who no longer respond to Roche's and Genentech Inc.'s rival product, Herceptin.

Patients should have also tried anthracycline and taxane chemotherapy drugs such as Sanofi-Aventis' Taxotere, or Bristol-Myers Squibb's Taxol.

"New targeted therapies such as Tykerb are helping expand options for patients," said Dr. Steven Galson, head of the FDA's Center for Drug Evaluation and Research.

Glaxo shares recovered earlier losses after the news to close down 75 cents at $55.25.

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