Roche Holding AG asked U.S. regulators to keep Avastin on the market for breast cancer in what the drugmaker called a “middle-ground proposal” while it conducts another clinical trial.
Roche asked the Food and Drug Administration to allow Avastin’s use together with the chemotherapy paclitaxel in patients with aggressive cancer and few options for treatment, according to a docket filed on Aug. 4. The drugmaker said it also plans a 480-patient trial, with failure triggering immediate voluntary withdrawal of Avastin for breast cancer.
The appeal is Roche’s latest effort to prevent withdrawal of Avastin’s approval in the U.S. An FDA panel ruled in June that use of the drug in breast cancer should be stopped because it didn’t work as well in follow-up studies and can cause deadly bleeding. Roche’s proposal would focus Avastin’s use on patients with more severe cancer that’s less likely to respond to chemotherapy, said Daniel Grotzky, a company spokesman.
“We’re open to discussing limitations on the marketing,” Grotzky said in a telephone interview today.
The Roche proposal also provides for a risk-evaluation strategy to give doctors and patients more information about Avastin’s effectiveness and risks. The follow-up patient trial would include a biomarker to help determine which patients benefit most. Roche had previously said it wanted to test a hypothesis that higher levels of a protein in the blood known as VEGF-A may identify whom the drug is likely to benefit.
Avastin is approved for lung, brain, kidney and colon tumors. Doctors can prescribe the drug “off label” in breast cancer even if approval is revoked, though insurers may no longer pay the $8,100-a-month price. The treatment’s global sales last year totaled 6.46 billion Swiss francs ($8.73 billion), or 14 percent of Roche’s revenue.
The drug remains on the market for breast cancer in Europe. It will remain available for U.S. breast cancer patients until FDA Commissioner Margaret Hamburg makes a final ruling.