GSK expands use of Hycamtin in treating cancer
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Hycamtin (topotecan HCl) for Injection from GlaxoSmithKline (GSK). The FDA has also agreed to a Priority review.
The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Hycamtin (topotecan HCl) for Injection from GlaxoSmithKline (GSK). 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 or radiation therapy.
The application is based on results from a randomised, multicenter Phase III trial, designed and conducted by the Gynecologic Oncology Group (GOG).
Hycamtin, currently marketed in the US by GSK, belongs to a class of drugs known as the topoisomerase I (topo-I) inhibitors and is indicated for treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy and for the treatment of metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.