FDA accepts sNDA on GSK's Hycamtin

UK drug major GlaxoSmithKline says that its supplemental New Drug Application submitted to the US Food and Drug Administration on December 15, 2005, for Hycamtin (topotecan HCl) for injection, has been accepted.

The FDA has also agreed to a priority review of the sNDA, which is seeking marketing approval for the new use of Hycamtin, in combination with cisplatin, for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy.

The application is based on results from a randomized, multicenter Phase III trial, designed and conducted by the Gynecologic Oncology Group, which demonstrated a survival advantage with the use of Hycamtin in combination with cisplatin compared to the latter alone.