Class/mechanism: Topoisomerase I inhibitor. Topotecan binds to the topoisomerase I-DNA complex and prevents the religation of single strand breaks that were originally created by topoisomerase I. This leads to double strand DNA damage, which results in cell damage and cell death.
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Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 5/28/1996: Initial FDA approval for metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
- 11/30/1998: Indication expanded to include small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy.
- 6/14/2006: Indication expanded to include stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
Also known as
- Code name: SKF S-104864-A
- Brand names: Hycamtin, Topecan, Topotec