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http://query.nytimes.com/gst/abstract.html?res=F60A13FF3A580C758CDDAC0894DB404482

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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