New Drug Developed for Lung Cancer

A new drug is designed as a monotherapy for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of both platinum-based and docetaxel chemotherapies. The drug, gefitinib (Iressa), has been cleared by the US Food and Drug Administration (FDA) for treating advanced NSCLC, where no approved treatment existed before.

A phase II trial studied two doses of Iressa in 216 patients who received both platinum-based and docetaxel chemotherapies. In the group of 142 patients receiving the recommended dose of 250 mg/day, 13.6% had their tumor shrink by at least 50%. Higher doses did not give a better response. The overall response rate for both doses combined was 10.6%. Median duration of response was seven months (ranging from 4.4 to 18.9 months). The effectiveness of Iressa is based on objective response rates. There are no controlled trials as yet demonstrating a clinical benefit such as improvement in disease-related symptoms or increased survival. Controlled trials of first-line treatment of NSCLC showed no benefit from adding Iressa to doublet, platinum-based chemotherapy. Therefore, Iressa is not indicated for use in this setting. Phase IV clinical trials of Iressa are being completed.

Iressa is the first in a new class of drugs that work differently from cytotoxic chemotherapy drugs commonly used for lung cancer. The drug was developed by AstraZeneca (London, UK).

"It is a welcome development to see people with lung cancer, who have no other threatment options available, respond to a new drug,” said trial investigator Mark G. Kris, M.D., chief of thoracic oncology, Memorial-Sloan Kettering Cancer Center (New York, NY, USA).