FDA Restricts Access to Lung Cancer Medication Iressa

FDA on Friday restricted access to the lung cancer medication Iressa, manufactured by AstraZeneca, to current or previous users and clinical trial participants after the medication failed to improve survival rates in two trials, the New York Times reports. FDA in 2003 awarded Iressa accelerated approval after a small trial found the medication reduced the size of tumors in about 10% of participants whose lung cancer did not respond to other treatments. However, larger trials found that Iressa did not improve the survival rates of participants.

FDA will allow patients who currently use and benefit from Iressa or have previously used and benefited from the medication to continue their use indefinitely. In September, patients who meet the criteria will have to fill Iressa prescriptions through a designated mail-order pharmacy and document their eligibility, according to AstraZeneca. About 4,000 U.S. residents use Iressa (Pollack, New York Times, 6/18). According to the AP/Philadelphia Inquirer, the move by FDA to restrict access to Iressa marks the first time the agency has limited use of a cancer medication that received accelerated approval (Neergaard, AP/Philadelphia Inquirer, 6/18).

The move comes amid criticism that pharmaceutical companies do not complete promised follow-up trials on medications that receive accelerated approval from FDA. Many patients who would have used Iressa currently take Tarceva, a similar medication developed by OSI Pharmaceuticals and Genentech that improved survival rates in a trial.

Richard Pazdur, director of the FDA Office of Oncology Drug Products, said, "One of the issues that we were very concerned about was not disrupting the supply of the drug for individual patients" (New York Times, 6/18). Padzur added that the move by FDA to restrict access to Iressa does not mark a "sea change in accelerated approval or a toughening of standards" (Wilde Mathews, Wall Street Journal, 6/20).

Sidney Wolfe, director of the Health Research Group at Public Citizen -- which has lobbied FDA to remove Iressa from the market -- said the agency should have withdrawn the medication and allowed current users to participate in clinical trials.

Laurie Fenton, president of the Lung Cancer Alliance, said the move could affect patients who have not used Iressa but have exhausted other treatment options.

Steven Walker, adviser to the Abigail Alliance for Better Access to Developmental Drugs, said, "It appears the FDA is waging war on cancer patients instead of on cancer." AstraZeneca will continue with a new trial of Iressa, with results expected in early 2007. According to the Times, evidence exists that Iressa "works best in Asians, nonsmokers and people whose tumors have particular mutations," confirmation of which could lead to expanded use of the medication.

Mary Lynn Carver, a spokesperson for AstraZeneca, said, "The science just needs to catch up in order for Iressa to have another chapter" (New York Times, 6/18).