Breast Cancer Drug Maker to Appeal FDA Ruling
Makers of the breast cancer drug Avastin have asked the U.S. Food and Drug Administration (FDA) to keep the drug on the market while it conducts another clinical trial, Bloomberg reports.
Roche Holding AG has asked federal regulators to allow Avastin to be used in conjunction with the chemotherapy drug Paclitaxel in patients with aggressive cancer and few options for treatment, according to a docket filed on Aug. 4.
Roche said it also plans to conduct a 480-patient trial. If the trial is a failure, Roche will immediately voluntarily withdraw Avastin for use as a breast cancer drug from the market, Bloomberg reports. “We’re open to discussing limitations on the marketing,” company spokesman Daniel Grotzky told Bloomberg in a telephone interview Tuesday.
Avastin is approved for lung, brain, kidney and colon tumors. Doctors can prescribe the drug “off label” in breast cancer patients even if FDA approval is revoked, though insurers may no longer provide coverage for the $8,100-a-month drug.
An FDA panel ruled in June that use of Avastin as a breast cancer treatment should be stopped because it didn’t work as well in follow-up studies and can cause deadly bleeding. Avastin remains on the market as a breast cancer drug in Europe and will remain available for U.S. breast cancer patients until FDA Commissioner Margaret Hamburg makes a final ruling.