The favourable decision was based on the review of data from four clinical trials conducted on patients with relapsed small cell lung cancer. Median survival and time to progression were also comparable for both treatment groups. Hycamtin is also approved for use in the treatment of ovarian cancer after failure of initial or subsequent chemotherapy. There is currently no standard treatment for this malignancy, which is one of the most deadly cancers among both men and women.
Lung cancer is the leading cause of cancer death in the United States.
In fact, more people die from lung cancer each year than from colon, prostate and breast cancer combined. Approximately two-thirds of all SCLC patients have extensive metastases at the time of diagnosis and nearly all patients with extensive disease will relapse after initial treatment. The FDA based its decision in part on a large Phase III, randomised clinical trial that was conducted at 44 centres in North America, Europe, and South Africa and involved 211 patients who had relapsed at least 60 days after their initial treatment. Tumours were assessed by radiologic evaluation and required independent confirmation. Median survival and time to progression were comparable for both treatment groups.