GlaxoSmithKline submits supplemental application for Hycamtin
21 February 2006 00:00 in Company product news
GlaxoSmithKline has announced that the supplemental New Drug Application (sNDA) submitted to the US Food and Drug Administration (FDA) in December 2005 for Hycamtin (topotecan HCl) for injection, has been accepted.
The UK company said that 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.
Based on the results from a randomised multicenter Phase III trial, the application was designed and conducted by the Gynecologic 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.
"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."
Earlier this month the European Commission approved Hycamtin (topotecan powder for concentrate for solution for infusion) for use as a treatment for patients with relapsed small cell lung cancer (SCLC) in whom repeat treatment with the first-line regimen is not considered appropriate.
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