GlaxoSmithKline's Hycamtin approved to treat cervical cancer in combination chemotherapy

By Elaine Rigoli

Tampa, Fla., June 15 - The Food and Drug Administration has approved GlaxoSmithKline's Hycamtin (topotecan HCl) 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 3 results that demonstrated a survival advantage by using Hycamtin in combination with cisplatin compared to cisplatin alone.

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.

The results show that Hycamtin extended the survival of these women, which the company said is the ultimate goal.

GlaxoSmithKline is a London-based pharmaceutical and health care company.

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