GlaxoSmithKline has been boosted by the news that the European Medicines Agency has granted marketing approval for the firm’s Hycamtin (topotecan) to be used as a treatment for cervical cancer in combination with the chemotherapy drug cisplatin.
GSK said the expanded indication is based on Phase III data that demonstrate a survival advantage by using Hycamtin in combination with cisplatin, compared to cisplatin alone, though the EMEA gave the approval with the proviso that “patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.”
The US Food and Drug Administration approved the combination treatment in June and this latest green light came as no surprise as Europe's Committee for Human Medicinal Products had already signalled its approval in October with a positive recommendation for the drug.
Andrew Witty, president of European pharmaceuticals at GSK, noted that more than 40 drug regimens have been tested against incurable cervical cancer and “despite this, there is no approved therapy. The combination of Hycamtin and cisplatin is now the only approved therapy representing a significant advance.” The company noted that, across Europe, there are around 60,000 reported cervical cancer cases and an estimated 30,000 deaths each year.
Hycamtin was originally approved for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent therapy and its indication was later expanded to include the treatment of small cell lung cancer disease for those whom re-treatment with first-line chemotherapy is not appropriate.