GlaxoSmithKline received approval from the FDA for Hycamtin 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 demonstrated a survival advantage by using Hycamtin in combination with cisplatin compared to cisplatin alone.

The randomized, multicenter trial found that Hycamtin, in combination with cisplatin, was effective in treating cervical cancers, which were not amenable to curative treatment with surgery and/or radiation therapy. The study showed a statistically significant improvement in overall survival for Hycamtin plus cisplatin arm. Median survival for Hycamtin plus cisplatin was 9.4 months when compared to 6.5 months for cisplatin alone.