GSK's Hycamtin gets FDA OK

The US Food and Drug Administration has approved UK drug major GlaxoSmithKline's anticancer agent Hycamtin (topotecan) for the treatment of relapsed small-cell lung cancer. Specifically, the drug has been cleared for patients who have achieved a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of treatment. The FDA's decision is based on the results of a Phase III multicenter trial in which 141 relapsed SCLC sufferers were randomized to receive a 2.3mg/m2 oral dose of the drug on days one through five of a 21-day cycle, plus best supportive care, or BSC alone. Those treated with the combined regimen experienced a statistically-significant improvement in overall survival, compared with members of the BSC group (25.9 weeks versus 13.9 weeks).