FDA Gives Conditional OK to Avastin for Breast Cancer
In a rare move, the FDA goes against a panel recommendation on a cancer drug.
Feb. 22, 2008— -- The U.S. Food and Drug Administration Friday afternoon granted a conditional approval for Avastin to treat breast cancer patients -- despite a recommendation by an FDA expert advisory panel in December to reject the new use.
The FDA has traditionally approved drugs for late-stage cancer only if they extended or improved the quality of patients' lives. In this case, the agency's decision to approve Avastin was based on the drug's tumor-shrinking abilities.
Some experts say the basis of this decision has huge implications for the future of breast cancer drug treatments.
"The FDA's approval process for Avastin tells us that regulators are now making quality-of-life issues an important part of their decision-making," said Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.
Avastin, a drug already approved for the treatment of colon and lung cancer, was OK'd for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows the agency to green light products for cancer or other life-threatening diseases based on initial positive clinical data.
Full approval of the drug is pending on the FDA's complete review of three additional randomized trials on Avastin, which have been submitted by Genentech.
Going by the current research available on Avastin, some cancer experts contend that there is simply not enough data in support of the drug to warrant full FDA approval.
"I would have voted against approval," said Dr. Anthony Elias, director of the Breast Cancer Research Program at the University of Colorado Health Sciences Center. "One trial that is negative [on Avastin] and one trial [that is] positive does not give a clear answer."
The study that Genentech, Avastin's manufacturer, submitted to the FDA found that using Avastin in combination with Taxol, a breast-cancer drug made by Bristol-Myers Squibb Corp., delayed the growth of patients' tumors for 11.3 months -- 5.5 months longer than Taxol alone.
