FDA Approves Iressa for Seriously Ill Lung Cancer Patients
The FDA yesterday approved the cancer medication Iressa, manufactured by AstraZeneca, for seriously ill lung cancer patients who no longer respond to standard treatments, the Wall Street Journal reports. Under the terms of the approval, AstraZeneca must conduct additional studies on the effectiveness of the treatment (Naik/Abboud, Wall Street Journal, 5/6). Iressa represents the first of a new class of prescription drugs called epidermal growth-factor-receptor blockers, which disrupt the chemical signals that prompt the growth of cancer tumors (Loyd, Philadelphia Inquirer, 5/6). The FDA approved the medication, which has a lower incidence of side effects than chemotherapy, for use in patients with advanced nonsmall-cell lung cancer who have received chemotherapy in the past under an expedited review process for serious diseases that have no available treatments. Patients must take one 250 milligram dose of the medication each day (Wall Street Journal, 5/6). AstraZeneca has received reports of 246 deaths and 592 cases of interstitial lung disease that resulted from Iressa in Japan, where regulators approved the medication last summer, but FDA officials said that the benefits of the medication outweigh the risks for advanced-stage lung cancer patients. "With approval of Iressa, thousands of patients with lung cancer will now have access to an additional treatment, after others haven't worked to stop the progression of their disease," FDA Commissioner Mark McClellan said (Philadelphia Inquirer, 5/6).
The FDA will require AstraZeneca to conduct three additional studies to confirm that Iressa helps patients live longer, to determine which patients benefit most and evaluate long-term safety. David Brennan, president and CEO of the U.S. division of the company, said that the results of the three studies would become available within the next two years. Brennan added that AstraZeneca has begun to conduct hundreds of studies on the effectiveness of Iressa as a treatment for other cancers, such as breast, head, neck and prostate cancers (Wall Street Journal, 5/6). AstraZeneca plans to begin to ship Iressa to pharmacies in two weeks; the medication will have a retail price of about $1,900 per month, the AP/Nando Times reports (Neergaard, AP/Nando Times, 5/5).
According to analysts and patient advocacy groups, the approval of Iressa marks a "new sign of flexibility" by the FDA in the approval process for new medications for serious diseases, the New York Times reports. Some patient advocacy groups have said the FDA in the past has "demanded too heavy a burden of proof for drugs, even when patients would die anyway," the Times reports. In recent weeks, however, FDA officials have told pharmaceutical companies that the agency would work with them on approvals for new medications for diseases that have no available treatments. "I think the new commissioner is listening to the public and is concerned about the need to get life-saving medicines to patients much sooner," Frank Burroughs, president of the Abigail Alliance for Better Access to Developmental Drugs, said. Stuart Weisbrod, chief investment officer at Merlin Biomed, added, "The FDA is approving things faster than people thought they would approve them and they're looking mainly at safety," rather than at effectiveness. However, Ira Loss, senior health care analyst at Washington Analysis, said, "Certainly there's a little flurry of activity here in the last couple of weeks that might lead one to conclude that something has changed, but I don't think it has." Meanwhile, some consumer advocacy groups also criticized the approval of Iressa. Peter Lurie, deputy director of the Health Research Group at Public Citizen, said, "There is a lowering of the bar that is close to unprecedented in the FDA drug approval process" with the approval of the medication (Pollack, New York Times, 5/6).
According to a Wall Street Journal editorial, the FDA, which "insists on putting procedure ahead of patients" in many cases, "continues to play against type and do the right thing" with the approval of Iressa. The FDA in the past has required "lengthy, complicated trials that tie up hopeful drugs in a maze of statistics, while real patients die waiting," but in the case of Iressa, the agency approved the medication based in large part on the support of an FDA advisory committee of oncologists, the editorial states. According to the editorial, the "lesson here is that the clinical ... deserves to play a bigger role in drug approvals," which in the past "has been driven by bureaucrats who may be statistical wizards but are more attuned to political pressure than to patient suffering." The editorial adds, "Knowing that real doctors will be involved would also encourage drug companies to take the risks necessary to create groundbreaking treatments." In addition, the editorial states that McClellan "has set about doing the much harder task of making the FDA bureaucracy more responsive to innovation and the needs of the sick," adding, "The approval of Iressa suggests that FDA employees are getting the message. And cancer patients are the better for it" (Wall Street Journal, 5/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.