WASHINGTON -- A Genentech drug received federal approval on Friday to treat breast cancer, a surprise decision that could represent a shift in standards for assessing the effectiveness of cancer medicines.
An image courtesy of Genentech shows a tumor attached to a blood vessel metastasizing to other organs within the body. US regulators approved Genentech's cancer drug Avastin for the treatment of breast cancer, the company said on Friday, adding a potentially significant new revenue source for the medicine. [Agencies] |
Going against the recommendation of its advisory panel, the Food and Drug Administration judged the effectiveness of Avastin based on measurements of tumor growth, not patient survival.
The ruling prompted a mixed reaction from both doctors and advocates for breast-cancer patients.
Some bemoaned the lowering of medical standards, but others applauded the federal government's endorsement of a drug that is already prescribed "off-label" to an estimated 9,500 patients and for whom insurance coverage is limited.
Avastin, which is already approved in the US for treating lung and colon cancer, was Genentech's best-selling product last year with revenue of $2.3 billion. Through a partnership with Genentech, Swiss drug maker Roche markets the drug in Europe, where it had previously been approved as a breast-cancer treatment.
