The panel's recommendation, although not binding, will be considered by the FDA in its review of the Supplemental New Drug Application submitted by Lilly in August 1997. The large pivotal trial showed that Gemzar in combination with cisplatin, a commonly-used anticancer medicine, significantly prolonged survival, slowed disease progression and shrank tumours compared with cisplatin alone. Patients who received the combination regimen had generally manageable side effects.
Lung cancer remains the world's most prevalent form of cancer.
It is the leading cause of cancer deaths among men and women and non-small cell lung cancer accounts for about 75 percent of all cases. Among women, reports ACS, lung cancer cases have increased 159 percent from 1973 to 1993 largely due to increased cigarette smoking. In the combination studies with Gemzar-cisplatin, myelosuppression, a reduction in blood cell counts, was the most common and severe side effect reported. Other commonly reported side effects included nausea and vomiting. Patients treated with Gemzar alone showed a tumour response rate and median time to disease progression that were similar to patients treated with cisplatin-etoposide.