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JNCI Journal of the National Cancer Institute 2002 94(21):1596-1597; doi:10.1093/jnci/94.21.1596
© 2002 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 94, No. 21, 1596-1597, November 6, 2002
© 2002 Oxford University Press

NEWS

Despite Concerns, FDA Panel Backs EGFR Inhibitor

Renee Twombly

The first 150 words of the full text of this article appear below.

An advisory panel for the U.S. Food and Drug Administration for the first time has recommended accelerated approval of a selective epidermal growth factor receptor (EGFR) inhibitor to treat cancer.

But it was not a clean victory for the agent, ZD1839 (also known as gefitinib or Iressa®), a daily pill designed to shrink tumors without producing the toxic side effects of chemotherapy. The FDA had released a report that was critical of the drug shortly before its Oncologic Drugs Advisory Committee (ODAC) met in September, and during the hearing, the committee itself issued several votes that appeared to be contradictory.


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  		AstraZeneca’s Iressa was recommended for accelerated FDA approval in September.

 
The ODAC agreed with the FDA in a 9-5 vote that the phase II studies backing the drug application that tested ZD1839 in advanced non-small-cell lung cancer made it impossible to adequately analyze data on patients’ symptoms. Yet, following . . . [Full Text of this Article]

Questions About Benefit

Sorting out Future Directions


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