• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

FDA approves topotecan hydrochloride (hycamtin) in combination with cisplatin for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix

On June 14, 2006, the U.S. Food and Drug Administration approved topotecan hydrochloride (Hycamtin, GlaxoSmithKline) in combination with cisplatin for the treatment of Stage IVB recurrent or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy.

Topotecan was evaluated in women with stage IVB recurrent or persistent cervical cancer in one open-label, multi-center, cooperative group trial.  Two hundred ninety-three patients were randomized to six cycles of topotecan 0.75 mg/m2 IV over 30 minutes for three consecutive days (Days 1-3) plus cisplatin 50 mg/m2 IV over 1 hour on Day 1 every 21 days or to cisplatin alone at the same dose and schedule.  The primary endpoint was overall survival.   The median survival was 9.4 months in the topotecan plus cisplatin group and 6.5 months in the cisplatin group (log-rank p = 0.033).  The unadjusted hazard ratio was 0.76 (95% CI: 0.59, 0.98).

The most common toxicity on the combination arm was myelosuppression.  Grade 3-4 hematologic adverse events occurring more commonly in the combination arm included neutropenia (74% vs. 2%), anemia (40% vs. 22%), thrombocytopenia (33% vs. 3%), and febrile neutropenia (18% vs. 8%).  Grade 3-4 non-hematologic adverse events reported more commonly in the combination treatment arm included pain, nausea and vomiting, metabolic-laboratory, and hepatic.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at Drugs@FDA.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by phone at 1-800-FDA-1088; by facsimile 1-800-FDA-0178 by mail using the Form 3500