FDA grants priority review of anti-cancer pill
Thursday, June 14, 2007
WASHINGTON, D.C. – June 14, 2007 – A capsule formulation of the anti-cancer drug topotecan (HYCAMTIN®) has been granted an FDA priority review expected to speed the oral treatment for a deadly form of lung cancer through the FDA approval process.
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The priority review was based on the first randomized study ever to show increased survival in patients treated with chemotherapy for relapsed small-cell lung cancer.
"Small cell lung cancer is an aggressive cancer for which there are limited treatment options. We are encouraged that the FDA has agreed to consider ORAL HYCAMTIN for the treatment of patients with this devastating illness," said Dr. Debasish Roychowdhury, vice president, global clinical development, for GSK, the drugs maker. "Today's FDA filing acceptance is another important milestone in GSK's continuing efforts to develop treatment options to meet the medical needs of cancer patients and the physicians who treat them."
The encouraging results came from a large clinical study of ORAL HYCAMTIN plus best supportive care (BSC) compared to BSC alone in patients with relapsed small-cell lung cancer. The results followed similarly positive results reported by two other studies. BSC refers to treatments intended to control, prevent and relieve disease complications to improve comfort and quality of life for the patient, but are not intended to have any anti-tumor effects.
About 15 percent of patients with lung cancer have small-cell lung cancer, an aggressive and fast growing form of lung cancer. It is caused by an uncontrolled growth of cells beginning on the surface of the lung's breathing tubes (called bronchi) and tends to spread widely through the body making chemotherapy the most common treatment for all stages of SCLC.
The data demonstrating a survival benefit for patients treated with ORAL HYCAMTIN that was submitted to the FDA was previously published in the December 1, 2006 issue of the Journal of Clinical Oncology.
In the Phase III multicenter trial, 141 patients with relapsed SCLC not considered as candidates for standard IV therapy were randomly assigned to receive BSC alone (n = 70) or ORAL HYCAMTIN plus BSC n = 71).
Median overall survival with ORAL HYCAMTIN plus BSC was 25.9 weeks compared to 13.9 weeks with BSC alone. In addition, patients who received ORAL HYCAMTIN plus BSC showed a consistent trend towards greater symptom control and a slower worsening of overall health status compared to BSC alone. The most common side effect was a serious loss of infection-fighting white blood cells (neutropenia) that occurred in a third of the patients treated with HYCAMTIN.
Unlike IV HYCAMTIN, which requires five consecutive days of intravenous therapy every three weeks, ORAL HYCAMTIN will allow patients to be treated at home.
"The evaluation of an oral treatment is a crucial step towards helping SCLC patients maintain a higher quality of life," said John Eckardt, M.D., Director of Clinical Research for the Center for Cancer Care and Research, St. Louis, MO. "Given the heritage of IV HYCAMTIN, the prospect of offering a new, convenient therapeutic option for SCLC that can be taken at home and may prolong survival is exciting."
If approved by the FDA, ORAL HYCAMTIN will be the only oral single-agent chemotherapeutic drug approved for the treatment of SCLC after failure of first-line therapy. ORAL HYCAMTIN is not currently approved for patients with SCLC in any country.
SOURCE: GSK press release
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