FDA Advisory Committee Hearing Addresses Safety Concerns Related to Cancer Medication Iressa

An FDA advisory panel on Friday began discussing whether or not to remove Iressa, manufactured by AstraZeneca, from the market after data from a large clinical trial indicated that the treatment did not prolong lives, the New York Times reports (Pollack, New York Times, 3/5).

Consumer group Public Citizen petitioned FDA Friday to remove Iressa from the market because of its poor performance, the AP/Contra Costa Times reports. The group initially had opposed Iressa's approval, arguing it was dangerous for patients (Schmid, AP/Contra Costa Times, 3/7).

The medication, which received FDA approval in May 2003 under an accelerated approval program, treats patients with advanced lung cancer.

Advisory committee members are waiting to hear more information before voting on whether Iressa should be removed from the market, but committee members said they would not prohibit patients currently taking the medication from continuing to receive it. Panel members said they might change the Iressa's prescription instructions to show that Traceva, a similar lung cancer treatment proven to prolong lives, should be taken first (New York Times, 3/5).

In its report to the FDA panel, AstraZeneca stated, "The failure to reach statistical significance for survival in the overall population was completely unexpected," noting that Iressa has been successful at shrinking tumors in people of Asian descent and nonsmokers. AstraZeneca said a decision on whether to pull Iressa from the market should not be made until an analysis of data from the clinical trial is complete, likely in May or June (AP/Contra Costa Times, 3/7).

Dr. Otis W. Brawley, a panel member and oncologist at Emory University, said, "The development of this drug has been mishandled," adding, "It's been mishandled by AstraZeneca. It's been mishandled by this committee. We still haven't figured out how it should be used."

Dr. Peter Lurie, deputy director for health research for Public Citizen, said, "If this drug is not taken off the market on these grounds, it will make an absolute mockery" of the accelerated approval program (New York Times, 3/5).

In a separate study, which appeared last week in the Journal of the National Cancer Institute, scientists found a gene mutation involved in the development of some lung cancers that appears to occur only in nonsmokers.

That study, by doctors at the University of Texas Southwestern Medical Center, said that the gene mutation had increased sensitivity to Iressa. The same mutation was more prevalent in women and patients from Japan (AP/Contra Costa Times, 3/7).