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FDA Approves GlaxoSmithKline's Oral Drug for Breast Cancer

Reuters
Wednesday, 14 Mar 2007 | 9:30 AM ET

U.S. health regulators have approved GlaxoSmithKline'spill, Tykerb, for patients with advanced breast cancer after other treatments have failed, the company said on Tuesday.

The drug was cleared for once-daily use in combination with Roche Holding'soral chemotherapy drug Xeloda, or capecitabine, Glaxo said.

Glaxo's Cancer Pill Getting Green Light
GlaxoSmithKline's new pill Tykerb is getting a green light from the FDA to treat women with advanced breast cancer that other treatments couldn't stop. Jean-Pierre Garnier, GlaxoSmithKline CEO, discusses his company's new drug with CNBC's Mike Huckman.

Glaxo shares recovered earlier losses after the late afternoon news and closed down 75 cents at $55.25 on the New York Stock Exchange.

Tykerb's approval is expected to launch what Glaxo hopes will be a new era for its oncology business, which is looking to win U.S. clearance for four other cancer medications by 2010.

The Food and Drug Administration approved the drug, also known as lapatinib, for patients with HER-2 positive breast cancer who no longer respond to Roche and Genentech rival product, Herceptin.

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

Those with the HER-2 positive disease face a more aggressive cancer in which the human epidermal growth factor receptor 2 is over-expressed.

Some analysts expect Glaxo's drug to bring in yearly sales of about $1.35 billion, by 2010. If it were to win approval for more uses, that figure could jump as high as $4 billion a year, according to some estimates.

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