The supplemental New Drug Application (sNDA) submitted by GlaxoSmithKline to the US FDA on December 15, 2005 for Hycamtin (topotecan HCl) for Injection, has been accepted.
The FDA has also agreed to a priority review. The sNDA seeks 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 Gynaecologic Oncology Group (GOG).
Hycamtin is currently indicated for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy, and for the treatment of small cell lung carcinoma sensitive disease after failure of first-line therapy.
Cervical cancer is the third most common gynaecological cancer among American women, with close to 12,000 new cases diagnosed annually. "Prognosis is positive if the disease is discovered early; however, expectations drop dramatically for those patients with advanced stage disease," explains Kevin Lokay, vice president of Oncology and Acute Care at GSK. "We are committed to improving the options available for these patients, and we see our collaboration with the GOG, in submitting their pivotal trial results, as very important to our commitment and achieving that goal," Kevin Lokay added.
Hycamtin (topotecan HCl for Injection) is currently marketed in the United States by GlaxoSmithKline. It belongs to a class of drugs known as the topoisomerase I (topo-I) inhibitors.