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GlaxoSmithKline granted European approval for lung cancer drug

GlaxoSmithKline has announced that oral Hycamtin has received approval from the European Commission, for the treatment of patients with relapsed small cell lung cancer for whom re-treatment with the first-line regimen is not considered appropriate.

The approval was based on positive results from a Phase III study comparing topotecan hard capsules plus best supportive care (BSC ) to BSC alone in patients with relapsed small cell lung cancer (SCLC), in addition to Phase II and Phase III supporting studies.

Eddie Gray, president, pharmaceuticals Europe, GlaxoSmithKline (GSK), said: “Topotecan hard capsules provide physicians and patients with an alternative, effective treatment, with the added convenience of being administered orally.”