Iressa fails to show survival advantage
AstraZeneca has informed the United States Food and Drug Administration (FDA) that a large randomized study comparing Iressa (gefitinib) plus best supportive care to placebo plus best supportive care 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. A letter to prescribing physicians from AstraZeneca regarding this trial has posted at
FDA approved Iressa on May 2, 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. The approval for Iressa was given based on a 10% response rate under accelerated approval regulations. This approval requires 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.
AstraZeneca repored that Trial 0709 enrolled 1,692 patients from 210 study centers in 28 countries. The two treatment arms were well balanced for demographic and disease-related patient characteristics. AstraZeneca reported that gefitinib treatment was not associated with a significant survival improvement in the overall population (HR=0.89) with a median survival of 5.6 months for gefitinib-treated patients and 5.1 months for placebo-treated patients. AstraZeneca reported that gefitinib treatment was not associated with a significant improvement in the adenocarcinoma population HR=0.83 with a median survival of 6.3 months for gefitinib-treated patients and 5.4 months for placebo-treated patients.
AstraZeneca has suspended any further 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.
The FDA has released the following statement regarding the failure of this clinical trial of Iressa (gefitinib) to show an overall survival advantage in treating patients with lung cancer:
The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.
Patients currently taking Iressa should consult with their physicians as soon as possible; patients should not change their therapy without first consulting with their physicians.
Alternative therapies are available. FDA has approved Taxotere (docetaxel) and Tarceva (erlotinib), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies.
Consumer Inquiries regarding this issue should be directed to : 1-888-INFO-FDA