Priority review of Hycamtin leads to FDA nod for SCLC

October 18, 2007

Topotecan granted FDA approval for relapsed small cell lung cancer.

GlaxoSmithKline has received regulatory approval following priority review of topotecan (Hycamtin) for the treatment of relapsed small cell lung cancer (SCLC). The oral capsules are indicated specifically for patients who have had a complete or partial response to first-line chemotherapy and are at least 45 days from the end of treatment. According to Glaxo, topotecan capsules are the only single-agent chemotherapy to be approved for the treatment of SCLC after failure of first-line therapy. The approval was based on results of a phase III trial that showed topotecan plus best supportive care (BSC) was associated with prolonged survival when compared with BSC care alone (25.9 weeks vs. 13.9 weeks). Topotecan is a topoisomerase inhibitor. According to the manufacturer, the oral capsules will be available in 2008.

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