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Home > This Just In > FDA Approves IRESSA®

FDA Approves IRESSA® for Treatment of Advanced Non-Small Cell Lung Cancer

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IRESSA Is the First In New Class of Drugs for the Treatment of Advanced
Non-Small Cell Lung CancerOnly FDA Approved Option for Third Line Patients

WILMINGTON, DE–May 5, 2003
AstraZeneca Pharmaceuticals (NYSE: AZN) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for IRESSA® (gefitinib) for the treatment of advanced nonsmall-cell lung cancer (NSCLC). The regulatory package for IRESSA fulfilled the FDAs requirements for accelerated approval, created for life threatening conditions where a new drug provides meaningful therapeutic benefit over available therapies, or in the case of IRESSA, where no approved treatment exist. IRESSA is administered as a once-a-day 250 mg pill. It works differently than cytotoxic chemotherapy drugs commonly used for lung cancer.

FDA approval is based upon data from a U.S. Phase II trial that studied two doses of IRESSA in a total of 216 patients who received both platinum-based and docetaxel chemotherapies. Included in the FDA analysis were 142 of the 216 patients. In the group receiving the recommended dose of 250 mg/day, 13.6% (95% CI: 6.4-24.3) of the patients had their tumor shrink by at least 50%. Higher doses did not give a better response and more side effects were observed. The overall response rate for both doses combined in all 142 patients was 10.6% (95% CI: 6.0-16.8). Median duration of response was 7 months (range 4.4 to 18.6+ months). The response rates appeared to be highly variable in subgroups of the treated population (gender, smoking history and histology) varying from 4.6-29.4%.

IRESSA is indicated as a monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapies. The effectiveness of IRESSA is based on objective response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Results from two large, controlled, randomized trials in first-line treatment of NSCLC (INTACT I & II) showed no benefit from adding IRESSA to a doublet, platinum based chemotherapy. Therefore, IRESSA is not indicated for use in this setting. As part of this accelerated approval, AstraZeneca will be completing Phase IV clinical studies, which are designed to satisfy FDA requirements for full approval.

"AstraZeneca is extremely proud to have discovered IRESSA and to be the first company to deliver this new class of lung cancer treatment," said Sir Tom McKillop, Chief Executive, AstraZeneca PLC. "Drug discovery and development is often a long and challenging road. Seeing the impact that IRESSA has made with patients and physicians makes the journey very rewarding for all of us."

"It is a welcome development to see people with lung cancer, who have no other treatment options available, respond to a new drug," said Mark G. Kris MD, Chief of Thoracic Oncology, Memorial Sloan Kettering Cancer Center and IRESSA clinical trial investigator.

"Lung cancer kills more Americans than breast, prostate and colorectal cancers combined. Unfortunately, most people that are diagnosed with lung cancer can not be cured by surgery," said Peggy McCarthy, founder of the Alliance for Lung Cancer Advocacy, Support and Education (ALCASE). "New treatments like IRESSA are desperately needed to give these patients and their families an alternative when chemotherapy fails."

The most frequent drug-related adverse events associated with IRESSA were diarrhea (48%) sometimes associated with dehydration, rash (43%), acne (25%), dry skin (13%), nausea (13%), and vomiting (12%). These events generally occurred within the first month of therapy and usually were mild to moderate. 2% of patients stopped taking IRESSA due to an adverse drug reaction. Infrequent cases (about 1%) of interstitial lung disease (ILDdescribed as interstitial pneumonia, pneumonitis, and alveolitis) have been observed in patients receiving IRESSA. Approximately 1/3 of the ILD cases were fatal. When ILD occurred, it was often accompanied by acute onset of breathing difficulty with cough or low grade fever requiring hospitalization. The reported incidences of ILD in the 23,000 patient US expanded access program was about 0.3%. In Japanese post-marketing experience the reported rate of ILD was about 2%. In the phase III controlled studies in combination with chemotherapy, there were similar rates of ILD (about 1%) reported in both the placebo and IRESSA arms of the study. IRESSA may cause fetal harm if administered to a pregnant woman. Asymptomatic increases in liver enzymes and eye irritation have also been observed in patients receiving IRESSA. Increases in bleeding events have been observed in cancer patients taking warfarin and IRESSA.

Lung cancer is the leading cause of cancer deaths in the United States, estimated to account for approximately 157,000 deaths in 2003. NSCLC is the most common form of lung cancer, accounting for 80 percent of all lung cancer cases.1

Physicians and patients can obtain additional information about IRESSA by calling the AstraZeneca Cancer Support Network at 1-866-99-AZCSN (1-866-992-9276).

AstraZeneca (NYSE:AZN) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In the United States, AstraZeneca is a $9.3 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

  • For more information on AstraZeneca and full prescribing information please visit
  • For a copy of the US IRESSA product label, click here.

    This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2002.

    IRESSA is a trademark of the AstraZeneca group of companies.

    1 American Cancer Society (2002). "Cancer Statistics 2003" - . 2003;53:5-26

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