FDA Approves GlaxoSmithKline's Hycamtin Capsules for Patients with Lung Cancer

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.

The United States Food and Drug Administration’s oncologic drugs advisory committee has recommended the approval of SmithKline Beecham’s Hycamtin(R) (topotecan hydrochloride for injection) for the second-line treatment of sensitive small cell lung cancer.
The favourable recommendation was based on a review of data from four clinical trials conducted on patients with relapsed small cell lung cancer. In a randomised, phase III, comparative clinical trial, Hycamtin as a single-agent showed comparable efficacy to CAV, a commonly used triple-drug combination therapy for the treatment of relapsed small cell lung cancer. Median survival and time to progression were also comparable for both treatment groups.

Hycamtin is an anti-cancer drug developed by GlaxoSmithKline (GSK) as a treatment for relapsed small cell lung cancer (SCLC) in patients who have undergone and failed partial or complete first-line chemotherapy. The drug is available in injection and tablet forms.

Hycamtin (topotecan) capsules have been approved by the U.S. Food and Drug Administration to treat relapsed small cell lung cancer (SCLC), maker GlaxoSmithKline said Monday.

About 15 percent of lung cancer patients have SCLC, a fast-growing cancer that most often affects current or past smokers.

Approved for people who have completely or partially responded to chemotherapy, the drug will be available in 2008, Glaxo said in a statement.

Hycamtin, among a class of medicines called topoisomerase I inhibitors, may increase users' risk of neutropenia, a drop in white blood cell count that boosts a person's risk of infection. Other potential side effects include nausea, diarrhea, vomiting, fatigue, and hair loss (alopecia).