Just want to let you know the breaking news. On Tuesday, the Oncologic Drugs Advisory Committee recommended in a 12-1 vote that the FDA withdraw its approval of Avastin as a treatment for advanced breast cancer.
In 2008, Avastin was given accelerated and conditional approval by the FDA for metastatic breast cancer treatment. Its manufacturer, Genentech, a subsidiary of Roche, was then required to do further studies to confirm the benefit of the drug.
The two new studies sponsored by Roche showed Avastin did not meet the standards that BCA has long maintained for any new drug approved for treatment. We believe a drug should meet at least one of the following standards: 1) extend the life of the patient, i.e., improve overall survival, and/or 2) improve the patient's quality of life, and/or 3) cost less than therapies already available.
We agree with the committee's recommendation, and we're saddened that after all this time there's still no good option to offer patients when current treatments have failed. In the meantime, we'll continue to advocate for more effective, less toxic, and less costly treatments for women living with breast cancer.
You can read the written comments BCA sent to the committee here.
All the best,