Glaxo’s ‘Hycamtin’ wins approval by FDA

Source: Stock Market Digital

Date :16/10/2007 08:38:23

GlaxoSmithKline PLC announced Monday approval by the U.S. Food and Drug Administration for its Hycamtin capsules for the treatment of relapsed small cell lung cancer.

About 15 percent of lung cancer patients have SCLC, a fast-growing cancer that most often affects current or past smokers.

Also known as topotecan, Hycamtin, was approved to treat patients who had a complete or partial response to initial chemotherapy treatment and have stopped that treatment at least 45 days prior.

Approval

This approval was based on positive results from a Phase III study comparing HYCAMTIN capsules plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to Phase II and Phase III supporting studies.

Glaxo said it has submitted registration dossiers for Hycamtin capsules in Europe, Canada and other markets around the world.

The product will be available in 2008.

October 15 2007

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