Business/Financial Desk
| May 6, 2003, Tuesday
Drug's
Approval Hints at Flexibility In F.D.A.
Process
By ANDREW POLLACK (NYT) 1601 words
Late Edition - Final , Section C ,
Page 1 , Column 5
ABSTRACT
- Food and Drug Administration approves
AstraZeneca's drug Iressa for treating
people with lung cancer who have run out of
other options; drug is first of new class of
therapies that can attack tumors while
avoiding some of usual side effects of
chemotherapy; drug does not work for vast
majority of patients and is associated with
potentially fatal side effect, type of
pneumonia; FDA's decision that benefits of
drug outweigh risk is seen by some patient
advocates and by analysts as new sign of
flexiblity on part of FDA in viewing drugs
for life-threatening diseases; some advocacy
groups have criticized FDA, saying it has
demanded too heavy burden of proof for
drugs, even when patient will die anyway;
Frank Burroughs, president of Abigail
Alliance for Better Access to Developmental
Drugs, praises FDA Comr Mark B McClellan for
speeding up drug reviews; FDA officials say
there is no new leniency; La Jolla
Pharmaceutical says it will submit
application for approval of its drug Riquent
for treating lupus even though main clinical
trial of drug did not meet its goal; Corixa
Corp says FDA has delayed decision for three
months on Bexxar, its drug for non-Hodgkin's
lymphoma, but company's comments suggest it
is likely to win approval; chart; photo (M)
The Food and Drug Administration yesterday
approved a drug for treating people with
lung cancer who have run out of other
options.
The drug, AstraZeneca's Iressa, is the
first of a new class of therapies that can
attack tumors while avoiding some of the
usual side effects of chemotherapy like
anemia, increased risk of infections, nausea
and hair loss. In studies, it has been shown
to drastically shrink tumors, but only in a
small percentage of patients.
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