Iressa Promotion Halted After Disappointing Trial Results
12/17/2004 Rachael Myers Lowe www.cancerpage.com Disappointing clinical trial results lead drug maker AstraZeneca to stop promoting its targeted lung cancer drug Iressa (gefitinib). The company advised patients who are currently taking the drug to talk to their doctor as soon as possible. Those who want to continue taking Iressa will continue to get it, the company said. “It is our intention to continue to provide the product” to those who want it, Mary Lynn Carver, AstraZeneca’s director of oncology information, told cancerpage.com. The company announced today that initial analysis of a large clinical trial involving nearly 1700 patients shows that Iressa “failed to significantly prolong survival in comparison to placebo” in the overall population or in patients with cancer. “This is a huge surprise to the oncology community, to the FDA and to ourselves,” Carver said. In a letter to doctors posted on the AstraZeneca USA web site today, the company suggests physicians prescribing Iressa consider other options: “In light of positive survival data with other agents including another oral EGFR inhibitor, AstraZeneca urges you to consider other treatment options in the recurrent non-small cell lung cancer patient population.” Carver said the company was moving quickly to inform doctors about the test results because of the patients they treat. “The patients they are treating are highly refractory advanced lung cancer patients with only weeks to live in some cases,” she said. In the US, Iressa was approved as a third-line treatment for advanced non-small cell lung cancer patients only after [...]