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.”