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FDA approves GSK drug for late-stage cervical cancer

Philadelphia Business Journal - June 15, 2006

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One week after approving a cervical cancer vaccine developed by Merck & Co. Inc., the Food and Drug Administration has given the green light to a drug aimed at treating women in the late stages of the disease.

Federal regulators Thursday said they have granted approval for the use of the GlaxoSmithKline drug Hycamtin in combination with cisplatin to treat late-stage cervical cancer in patients whose cases are unlikely to be helped by surgery and radiation.

Hycamtin was approved by the FDA in 1996 for the treatment of ovarian cancer and small cell lung cancer.

Cisplatin is an inorganic compound commonly used in the treatment of a variety of tumors. It is marketed by Bristol-Myers Squibb as platinol.

The FDA's decision follows the June 8 approval of Gardasil, the first vaccine to protect women against cervical cancer, as well as precancerous genital lesions and genital warts, caused by four strains of human papillomavirus.

Gardasil is designed for use in females between the ages of 9 and 26.

Another company, GlaxoSmithKline, is pursuing FDA approval of a different cervical cancer vaccine called Cervarix.

In the United States, about 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.

London-based GlaxoSmithKline (NYSE: GSK) has dual U.S. headquarters in Research Triangle Park, N.C., and Philadelphia.

Based in Whitehouse Station, N.J., Merck & Co. (NYSE: MRK) has its vaccine operation based in West Point, Pa., outside Philadelphia.

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