The Washington Legal Foundation (WLF) and a team of three non-profit patient groups this week called upon the FDA to withdraw or modify its order for the relabeling of AstraZeneca’s lung cancer treatment Iressa.
“FDA’s action effectively limits the use of Iressa in the U.S. to the approximately 4,000 patients already being treated with it,” WLF said in a statement.
Joining WLF in the call for greater availability of Iressa are an alliance of three non-profit patient groups that includes the Abigail Alliance for Better Access to Developmental Drugs, The Lorenzen Cancer Foundation and The Lung Cancer Alliance.
In June, the FDA ordered that Iressa only be made available to patients for which the drug has previously demonstrated clinical benefit. “New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer that have shown an ability to make people live longer,” the FDA said.
Iressa generated $390 million in revenues last year, but sales have been falling in light of the FDA’s doubts over its efficacy.
Sales of the drug dropped from $93 million in the first quarter of 2004 to $81 million in the equivalent period of 2005.
At press time, the FDA had yet to respond to MM&M’s request for comment regarding the WLF statement.