teresag Posted December 17, 2004 Share Posted December 17, 2004 Copy of an email sent to the members of the Oncology Nursing Society: _____________________________________________________________ In collaboration with the Food and Drug Administration (FDA), and as a service to our members, the Oncology Nursing Society will provide drug development information about therapies for patients with cancer. This will allow the FDA to inform ONS members in a timely manner. The following is a message from Dr. Richard Pazdur: To: ONS membership From: Richard Pazdur, MD Director, Division of Oncology Drug Products Center for Drug Evaluation and Research, FDA AstraZeneca notified the United States Food and Drug Administration (FDA) that a large randomized study comparing Iressa (gefitinib) plus best supportive care (BSC) to placebo plus BSC failed to demonstrate a survival advantage for gefitinib in the treatment of non-small cell lung cancer (NSCLC) patients who have received 1 to 2 prior chemotherapy regimens (Trial 0709). A letter to prescribing physicians from AstraZeneca regarding this trial is posted at http://www.astrazeneca-us.com/modules/P ... ?id=211316 . Iressa was originally approved by the FDA on May 5, 2003, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression on both platinum-based and docetaxel chemotherapies. Iressa was approved based on a 10% response rate under accelerated approval regulations. These regulations allow approval based on a surrogate end point reasonably likely to predict clinical benefit and require subsequent demonstration of clinical benefit in further investigations. As an approval condition, AstraZeneca committed to conduct a randomized trial examining Iressa effect on survival in this patient population (Trial 0709). AstraZeneca reports that Trial 0709 enrolled 1,692 patients from 210 study centers in 28 countries. The last patient was enrolled on August 2, 2004, and the data cut-off was October 29, 2004. The two treatment arms were well balanced for demographic and disease-related patient characteristics. AstraZeneca reports that gefitinib treatment was not associated with a significant survival improvement in the overall population HR=0.89 (95%CI: 0.78, 1.03, p=0.11) with a median survival of 5.6 months for gefitinib-treated patients and 5.1 months for placebo-treated patients. AstraZeneca reports that gefitinib treatment was not associated with a significant improvement in the adenocarcinoma population HR=0.83 (95% CI:0.67, 1.02, p=0.07) with a median survival of 6.3 months for gefitinib-treated patients and 5.4 months for placebo-treated patients. AstraZeneca has suspended promotion of gefitinib while these trial data are further analyzed and will continue to make the drug available to patients who appear to benefit from treatment. Physicians are reminded that docetaxel (Taxotere) and erlotinib (Tarceva®) have received regular approval for this indication and that pemetrexed (Alimta®) has received accelerated approval. The product labels providing complete prescribing information are available at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. _____________________________________________________________ I am sharing this information so that people on Iressa may take appropriate action in collaboration with their health care provider. Those of you taking Iressa may wish to talk to your health care professional about these findings. They are still analyzing the data to determine if a subset of patients with specific markers do benefit from the drug. In other words, the final conclusions have yet to be reached and any action you take in response to this information must be in cooperation with your physician. Please note that the FDA URL above contains a list of drugs by brand name. The entry for Iressa does not yet include this updated information. This information was also released on Yahoo Healthcare News. Quote Link to comment Share on other sites More sharing options...
Join the conversation
You can post now and register later. If you have an account, sign in now to post with your account.