Special Notices

Iressa® Remains Commercially Available to Patients

Commitment from FDA and AstraZeneca to continue supplying IRESSA

Wednesday, December 22, 2004

On Friday, December, 17, 2004, AstraZeneca announced the results of a study showing that IRESSA® (gefitinib) (250mg tablet) plus "best supportive care" provided no survival advantage over a placebo plus "best supportive care" in patients with Advanced Non Small Cell Lung Cancer (NSCLC).

Since that announcement, ALCASE has received calls from current Iressa patients who are concerned as a result of this study that the drug will become unavailable or that FDA may take it off the market. ALCASE contacted Dr. Richard Pazdur, Director, Division of Oncology Drug Products, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for comment on this issue.

"The FDA is working with AstraZeneca to sort out the regulatory implications of this data. With that said, FDA has no intention of denying Iressa patients who feel they are receiving benefits from drug access," emphasized Dr. Pazdur." When asked to define what he meant by "benefit," he added: "if patients feel they are receiving benefit, they should be allowed to continue taking Iressa. I am including patient perceived quality of life benefit. They do not need to demonstrate objective tumor response or other measurable clinical outcome."

ALCASE also contacted AstraZeneca for comment concerning the continued availability of the drug to current Iressa patients. Mary Lynn Carver, spokesperson for AstraZeneca, said "AstraZeneca is working with the FDA and intends to continue to make the drug commercially available. AstraZeneca has made the decision to suspend advertising and promotion at this time while we continue to evaluate which patient groups may derive benefit from IRESSA.”

Physicians have been advised of the data as well as the further AstraZeneca and FDA efforts. Patients with questions are encouraged to discuss them with their physicians.