PFPC Daily - March 5, 2005

It is incomprehensible how this drug could have ever been approved by
the FDA in 2003 - after it was known that the drug had caused over
160 deaths in Japan!

SEE:
Iressa
http://64.177.90.157/pfpc/html/iressa.html

=============================

AstraZeneca Says It Is Shocked By The Non-Performance Of Lung Cancer
Drug Iressa

EarthNews - March 5, 2005

By Ryan Jones

A stunned AstraZeneca told an FDA advisory committee, which is
reviewing cancer medications, that it was going to conduct a detailed
analysis to find out precisely why Iressa turned out to be a dud in
follow-up studies.

Promoted by the company as a last-chance drug in the treatment
of lung cancer, Iressa showed promising results in preliminary
trials but failed to live upto the expectations in the follow-ups.
Iressa was granted approval by the Food and Drug Administration in
2003 and was meant for use in advanced lung cancer patients for
whom standard therapy has failed to produce any results.

Iressa shrank tumors in some terminally ill patients, but was
approved on the basis that further testing was required. However,
there was no significant improvement in the follow-up studies. This
prompted AstraZeneca to advise doctors not to promote the drug.

"The failure to reach statistical significance for survival in
the overall population was completely unexpected," the company
said. It went on to add that people of Asian descent and
nonsmokers benefited from the drug. Doctors at the University of Texas
Southwestern Medical Center, found that this group had a gene
mutation that caused an increased sensitivity to Iressa.

AstraZeneca has requested the FDA advisory committee not to make a
decision on the commercial availability of the drug till it completes
its analysis. The analysis is expected to be complete in May/June
2005. Meanwhile, Public Citizen, a US based citizens action group has
asked the FDA to take Iressa off the shelves.

SOURCE:
http://www.earthtimes.org/articles/show/1867.html