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May 12, 2003
Volume 81, Number 19
CENEAR 81 19 p. 9
ISSN 0009-2347


PHARMACEUTICALS

DRUG APPROVAL
New class of cancer drugs emerges as FDA takes action on more products

ANN THAYER

Iressa
AstraZeneca's anticancer drug Iressa is the first epidermal growth factor receptor (EGFR) inhibitor to get FDA's blessing. The approval not only ushers in a new class of drugs but also may reflect an attitude shift at FDA. However, the reaction to Iressa's approval last week was mixed.

Iressa targets advanced non-small-cell lung cancer in patients who have not responded to two types of chemotherapy. With no other treatment available, FDA granted accelerated approval based on Phase II clinical trial data showing that 13.6% of patients had tumors shrink at least 50%. Iressa is a once-per-day pill without the typical severe side effects of traditional chemotherapy.

However, about 0.3% of U.S. patients taking Iressa developed severe lung disease and about one-third of those died. A 2% rate of lung disease has occurred in Japan since the drug was approved there in July 2002. Because of this, groups including Public Citizen have opposed Iressa's approval, calling it "likely ineffective and dangerous."

FDA says it carefully reviewed the Japanese data and believes the "probable benefit of Iressa outweighs its risks." As a condition of FDA's approval, AstraZeneca still must conduct postmarketing studies and demonstrate Iressa's therapeutic benefit. Public Citizen says such trial data already exists and is "unambiguously negative."

Iressa blocks growth signals in cancer cells mediated in part by tyrosine kinases, including one associated with EGFR. Several partnerships--including OSI Pharmaceuticals, Roche, and Genentech; Abgenix and Amgen; and ImClone Systems and Bristol-Myers Squibb--as well as AstraZeneca are developing competing EGFR inhibitors in several cancers.

A recent spate of approvals is being viewed positively by the pharmaceutical industry, which waited nearly two years for a permanent FDA commissioner. After just two months on the job, Mark B. McClellan announced plans in January to expedite the regulatory process without sacrificing safety.



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Related Sites
AstraZeneca

Iressa

epidermal growth factor receptor (EGFR)

FDA

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