WASHINGTON, DC: Weber Shandwick aided Genentech on communications work leading to approval from the Food and Drug Administration (FDA) of Avastin, a drug used in treating metastatic breast cancer, sources told PRWeek. On February 22, the FDA gave the biotech company permission in a surprising move that went against the advice of its own advisory panel.
Genentech and WS did not return calls for comment on communication efforts leading up to its approval by press time. The FDA's decision was an important moment for Avastin, as doctors had already been using the drug off-label for that treatment. If the FDA ruled against the drug, it could have made insurers less likely to cover the off-label use.
The approval could mean a new set of standards for the FDA when it examines the effectiveness of cancer drugs, because Avastin was approved with evidence that it slowed tumor growth, known as the "progression-free survival" benefit. Usually cancer medications must be shown to extend life or improve quality of life, and neither condition was met by Avastin. In 2004, the FDA approved the drug for the treatment of colon and lung cancer.