GlaxoSmithKline has received the thumbs up from Europe’s drug advisory board, the CHMP, to expand the labelling for its oncology agent Hycamtin (topotecan) in the second-line treatment of patients with small cell lung cancer. The UK giant says Hycamtin is the first drug to receive a positive opinion from the CHMP for treating relapsed SCLC.
The nod from Europe followed presentation of three clinical studies – the first compared Hycamtin to a triple regimen of conventional therapy in patients with sensitive SCLC and found both arms comparable in terms of overall survival. The second trial evaluated oral Hycamtin with an intravenous form of the drug, and found again that the two treatment groups were comparable in terms of overall survival and tolerability. Finally, the third study was designed to investigate the survival benefit of second-line chemotherapy for relapsed patients, using oral Hycamtin plus best supportive care versus the latter alone, overall survival was 26 weeks amongst patients given GSK’s drug, compared to 14 weeks in those receiving best supportive care.
Lung cancer is the leading cause of cancer-related death in the world and this is the second label for Hycamtin in Europe; it was first approved for the second-line treatment of advanced ovarian cancer.