Avastin, the blockbuster drug that just lost approval for treating breast cancer, now looks disappointing against ovarian cancer, too. Two studies found it did not improve survival for most of these patients and kept their disease from worsening for only a few months, with more side effects.
The Genentech drug won approval in Europe last week for advanced ovarian cancer. But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, "we do not believe the data will support approval" although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche.
Results of the studies are in today's New England Journal of Medicine.
In November, the FDA revoked Avastin's approval for breast cancer because it did not meaningfully extend life and can have serious side effects. Without approval, doctors can prescribe the drug but insurers may not pay. Treatment with it can cost $100,000 a year.
One study, led by Dr. Robert Burger of Fox Chase Cancer Center in Philadelphia, involved nearly 1,900 with advanced ovarian cancer given one of three treatment combinations. Survival was similar among the groups, and side effects were higher among those on Avastin -- mostly high blood pressure.
In the other study, led by researchers from England, more than 1,500 ovarian cancer patients were given chemo with or without Avastin. The drug kept cancer at bay one to two months longer than chemo alone did, with more cases of high blood pressure.