Expanded US label for GSK's Hycamtin

UK drug major GlaxoSmithKline says that the US Food and Drug Administration has approved its topoisomerase I inhibitor Hycamtin (topotecan) in combination with cisplatin, for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

Following a six-month priority review by the FDA, the expanded indication is based on Phase III results that demonstrate a survival advantage for Hycamtin in combination with cisplatin versus cisplatin alone.

Patients in the randomized, multicenter trial showed a statistically-significant improvement in overall survival with Hycamtin and cisplatin (p=0.033). Median survival for the combination group was 9.4 months vs 6.5 months for cisplatin alone.