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 late in December 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 were published in the Dec. 29 edition of the 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.
Avastin can still be sold for some colon, lung, kidney and brain cancers. The new research was aimed at adding ovarian cancer to the list.
One study, led by Dr. Robert Burger of Fox Chase Cancer Center in Philadelphia, involved nearly 1,900 women with advanced ovarian cancer given one of three treatment combinations.
The time until the disease got worse was a median of 10 months in those given just chemotherapy; adding Avastin improved that by just one to four months for the other two groups.
Survival was similar among the groups, and side effects were higher among those on Avastin — mostly high blood pressure but also some stomach and gut problems that needed treatment.
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 just one to two months longer than chemo alone did, with more cases of high blood pressure.