MONDAY, May 5, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration gave accelerated approval Monday to AstraZeneca's drug to treat advanced cases of non-small cell lung cancer (NSCLC).
Approval of Iressa came only a few days after the consumer group Public Citizen urged the FDA not to OK the drug, saying it had shown serious side effects and caused a number of deaths in Japan. The Japanese results caused a delay in the approval, but the FDA said they weren't reason enough to bar the drug's use as a third-line cancer treatment. That means eligible patients must not have responded to two previous chemotherapy regimens.
Last fall, AstraZeneca revealed that Iressa had been taken by more than 10,000 people in Japan, but that the medication had been implicated in 39 deaths and caused serious cases of lung disease in 125 others. At the same time, in U.S. clinical trials, more than 13 percent of the 216 patients taking Iressa saw their tumors shrink by at least 50 percent, the company says. Nonsmoking women tended to respond to the therapy better than smokers or men.
The FDA's accelerated approval process allows a drug to be prescribed before its safety and effectiveness are fully understood. The program is implemented when the drug may be used to treat a life-threatening condition that has no proven cure.
Iressa is among a new class of drugs that target only cancer cells and are meant to leave healthy tissue alone. It prevents cancer from sending a signal that spurs healthy cells into over-reproducing, a typical marker of cancer. The drug's side effects include diarrhea, rash, and acne.
Lung cancer, of which NSCLC accounts for 80 percent of cases, is the leading cause of cancer death in the United States. It's expected to claim 157,000 lives this year.