The Food and Drug Administration on Friday repealed its approval of the drug Avastin for the treatment of breast cancer, a decision that reduces the arsenal of options for local oncologists.
The drug is still available as a treatment for some types of lung, colorectal, kidney and brain cancers.
Early trials of Avastin demonstrated a 5 1/2-month delay in the growth of metastatic breast cancer tumors. However, later trials only showed it to be a one- to two- month advantage.
The research also did not show any significant impact on survival rates. Weighing those findings against such risks as difficulty with wound healing and severe high blood pressure, the FDA concluded Avastin was more harmful than helpful.
“I do support the decision,” said Dr. Anthony Elias, oncologist and medical director of the breast cancer program at the University of Colorado Cancer Center. “I think what’s unfortunate is that the drug clearly has some active impact against breast cancer.
“I think what the FDA was saying was that progression-free survival was perhaps not sufficient if you have increased toxicities during the time. It offsets the benefit.”
The dozen or so CU Cancer Center patients who were using the drug have other treatment options, Elias said.
“The only situation we used it in was in a subset of breast cancer that was particularly aggressive called triple negative,” he said.
Rocky Mountain Cancer Centers used the drug regularly during its first two years on the market but cut back when warnings about the side effects began flaring in September 2010, said breast oncologist Dr. Dev Paul.
He said that before the repeal, 20 percent to 30 percent of Rocky Mountain Cancer Centers patients with metastatic breast cancer would have used the drug at some point in the treatment.
“It seemed like it worked pretty well for several patients,” Paul said. “But that’s the FDA’s decision.”
There are studies still ongoing that leave the drug’s fate uncertain.
“Who knows what the final word will be? I’m not too (happy) that they cut it,” Paul said.
“It just added one drug to the armamentarium,” Elias said. “We rarely run out drugs. It’s not a huge loss.”
Kristen Leigh Painter: 303-954-1638 or kpainter@denverpost.com
