GlaxoSmithKline plc announced that the European Medicines Agency (EMEA) has granted marketing authorisation for Hycamtin (topotecan HCl) in combination with cisplatin, for the treatment of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
The indication also includes the following qualifying statement that 'patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination'. The expanded indication is based on phase III results that demonstrate a survival advantage by using Hycamtin (0.75mg/m2 days 1-3) in combination with cisplatin (50mg/m2 day 1), compared to cisplatin (50 mg/m2) alone.
The marketing authorisation follows a positive opinion in October 2006 by the European Committee for Human Medicinal Products (CHMP) for Hycamtin.
"Advanced cervical cancer often has a very poor prognosis, even with current treatments, so new treatment options such as Hycamtin, represent welcome treatment advances for the many women facing this disease every year," said Professor Hani Gabra, Prof of medical oncology at the Hammersmith Campus of Imperial College London. "For patients with so few other options it is an encouraging step forward in the management of advanced/recurrent cervical cancer."
The randomised, multi centre trial was designed and conducted by the Gynaecologic Oncology Group (GOG) in the US and results were previously published in the journal of clinical oncology.1.
The study found that Hycamtin, in combination with cisplatin, was more effective in treating cervical cancers, which were not appropriate for curative treatment with surgery and/or radiation therapy, than cisplatin alone.
Andrew Witty, President of European Pharmaceuticals at GSK said, "GSK is focussed on closing in on cancer from all sides to ensure that we are not only helping the women of today who have cervical cancer but also those who may be at risk in the future. More than 40 drug regimens have been tested against incurable cervical cancer, despite this there is no approved therapy. The combination of Hycamtin and cisplatin is now the only approved therapy representing a significant advance."