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Glaxo anticancer drug gets new indication

The FDA has approved GlaxoSmithKline's Hycamtin for an expanded indication to treat recurrent cervical cancer in combination with cisplatin.

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.

Hycamtin was originally approved for the treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy and for the treatment of metastatic ovarian cancer after failure of initial or subsequent chemotherapy.

“Advanced cervical cancer can have a very poor prognosis, even with current treatments, so physicians are always looking for new and effective therapies,” said Dr Bradley Monk, associate professor, division of oncologic gynecology at University of California, Irvine. “These results show that Hycamtin extended the survival of these women, which is the ultimate goal.”