updated 6/17/2005 2:41:47 PM ET 2005-06-17T18:41:47

The government will allow only a few thousand lung cancer patients to continue using a last-chance therapy, after the highly touted Iressa failed to live up to its promise for most users.

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The Food and Drug Administration’s decision Friday means that patients with advanced lung cancer who believe the drug is helping them won’t lose access to it — but that after Sept. 15, any new patients who wish to try Iressa will have to do so in a strictly controlled research study.

About 4,000 Americans currently are taking Iressa, and fear that they would lose it had been building since March, when the drug failed to live up to expectations in a key study.

To curb new use of Iressa, beginning Sept. 15 it will sell only through one mail-order pharmacy, which will require special documentation of eligibility by the doctor and patient, maker AstraZeneca announced.

Fast-track drugs to get second look
It’s the first time the FDA has taken such action for a cancer treatment approved under its special program that lets promising therapies sell before final research proves whether they increase survival. The agency warns that it will soon assess whether other drugs allowed onto the market early have lived up to their expectations.

Iressa was one of the first so-called targeted cancer therapies when it hit the market in 2003 for advanced lung cancer. But doctors soon became flummoxed: Some terminally ill patients were reported to live months or even years longer than expected with the drug, but only about 10 percent of patients had any response to Iressa. It failed in most.

Last year, scientists found a possible explanation: Iressa targets a specific molecule that spurs growth of lung cancer cells, but it seems to work only in patients whose tumors have a certain gene mutation that’s more common among nonsmokers, women and Japanese patients. No one knows why.

That’s still a theory. Meanwhile last spring, Iressa failed in a key study the FDA had required for approval.

A balancing act
Deciding what to do was a balancing act, said FDA oncology chief Dr. Richard Pazdur.

“Obviously patients that are being treated for this condition are suffering from life-threatening disease. If somebody believes they are having benefit from the drug ... then they should continue having the drug,” he said.

But new patients should consider alternatives that have hit the market since Iressa, including another targeted therapy called Tarceva, Pazdur said.

While the restricted marketing is going on, AstraZeneca can continue research to see if the gene theory holds up and there are subsets of patients who might be appropriate candidates.

The restricted access only applies to Iressa sold in the United States, and will not increase the price, said AstraZeneca spokeswoman Mary Lynn Carver.

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