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FDA Approval for Topotecan Hydrochloride

Brand name(s): Hycamtin®

  • Approved for cervical cancer

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

On June 14, 2006, the U.S. Food and Drug Administration approved topotecan hydrochloride (Hycamtin®, made by GlaxoSmithKline) in combination with cisplatin for the treatment of stage IVB recurrent or persistent carcinoma of the cervix (cervical cancer) 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, multicenter, cooperative group trial. Two hundred ninety-three patients were randomized to six cycles of topotecan hydrochloride 0.75 mg/m2 IV over 30 minutes for three consecutive days (Days 1-3) plus cisplatin 50 mg/m2 IV over one 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 hydrochloride plus cisplatin group and 6.5 months in the cisplatin group (log-rank p = 0.033). The unadjusted hazard ratio was 0.76 (95 percent CI: 0.59, 0.98).

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

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

  • Updated: July 3, 2013