Hycamtin (topotecan hydrochloride)

Company
GlaxoSmithKline

Approval Status
Approved October 2007

Treatment for
small cell lung cancer

Possible similar drugs
Hycamtin

Areas
Cancer & Oncology

Hycamtin (topotecan) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks.

Hycamtin is specifically indicated for the treatment of relapsed small cell lung cancer in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

Hycamtin is supplied as a 0.25 mg and 1 mg capsule designed for oral administration. The recommended initial dose of the drug is 2.3 mg/m2/day once daily for 5 consecutive days, repeated every 21 days. The calculated oral daily dose should be rounded to the nearest 0.25 mg, and the minimum number of 1 mg and 0.25 mg capsules should be prescribed. The same number of capsules should be prescribed for each of the 5 dosing days.

FDA Approval
FDA approval of Hycamtin was based on the results of a clinical trial. This randomized, comparative, open label study enrolled 115 subjects who were prior responders (complete or partial) to firstline chemotherapy, were not considered candidates for standard intravenous chemotherapy, and had relapsed at least 45 days from the end of first-line chemotherapy. The subjects received Hycamtin (2.3 mg/m2/day administered for 5 consecutive days repeated every 21 days) and Best Supportive Care (BSC) or BSC alone. The primary endpoint was overall survival. Median survival in the Hycamtin arm was 25.9 weeks (95% CI, 18.3 to 31.6) versus 13.9 weeks (95% CI, 11.1 to 18.6) in the BSC alone arm (log-rank P = .0104).

The side effects associated with the use of Hycamtin may include, but are not limited to, the following:

  • Anemia
  • Leukopenia
  • Neutropenia
  • Thrombocytopenia
  • Nausea
  • Vomiting
  • Diarrhea

Hycamtin (topotecan) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity. Topoisomerase I relieves torsional strain in DNA by inducing reversible single strand breaks. Topotecan binds to the topoisomerase I-DNA complex and prevents religation of these single strand breaks. The cytotoxicity of topotecan is thought to be due to double strand DNA damage produced during DNA synthesis, when replication enzymes interact with the ternary complex formed by topotecan, topoisomerase I, and DNA. Mammalian cells cannot efficiently repair these double strand breaks.

For additional information regarding Hycamtin or small cell lung cancer, please visit the Hycamtin web page.

Hycamtin (topotecan hydrochloride) Drug Information

The Hycamtin (topotecan hydrochloride) drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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