Hycamtin gets EU OK for cervical cancer

UK-based drug major GlaxoSmithKline says that the European Medicines Agency (EMEA) has approved its anticancer agent Hycamtin (topotecan HCl), in combination with cisplatin, for the treatment of patients with cervical carcinoma that recurs following radiotherapy. The clearance, which includes the compound's use by patients with stage IVB disease, comes with the caveat that those who have received prior cisplatin-based therapy "require a sustained treatment-free interval to justify treatment with the combination."

The firm said that the approval is based on the results of a Phase III trial, which showed that the combined regimen was more effective at treating cervical cancers that were not appropriate for curative treatment than cisplatin alone.

The EMEA's decision, which follows similar clearance by the US Food and Drug Administration (Marketletter June 26), builds on the list of oncology indications, which include ovarian and non-small cell lung cancer, for which the agent is approved.