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Tuesday 21 February 2006

Supplemental New Drug Application Accepted for Hycamtin® in Treatment of Cervical Cancer


The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for GlaxoSmithKline’s chemotherapy agent Hycamtin (topotecan HCL) for Injection. The FDA has also granted priority review status to the new proposed indication.

The sNDA seeks marketing for Hycamtin used in combination with Platinol® (cisplatin) for the treatment of stage IVB cervical cancer that is recurrent or persistent and not considered curable with surgery and/or radiation therapy.

The current indication for Hycamtin is for treatment of metastatic ovarian cancer after failure of prior chemotherapy, and for treatment of small cell lung cancer sensitive disease following initial chemotherapy.

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