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After two days of sometimes emotional testimony, the U.S. Food and Drug Administration’s six-member Advisory Committee has unanimously determined Avastin—the best-selling cancer drug in the world—is neither safe nor effective in treating metastic breast cancer and it should be withdrawn.
The decision brought cries of protest from women in the galley-- primarily breast cancer survivors and their supporters who say the drug saved their life.
The FDA granted cancer drug maker Roche and its research partner, Genentech, a public hearing this week to appeal its earlier decision to withdraw the accelerated approval from Avastin’s label for women with incurable HER2 negative metastatic breast cancer. The meeting was unprecedented since the FDA has already ruled the drug neither extends nor improves life for breast cancer patients.
The FDA’s decision will not pull the drug off the market, but rather limits its use for colon, kidney, brain and lung cancers. The ruling will allow doctors to continue to prescribe Avastin “off label” or for an unapproved use, but insurers are unlikely to pay for it. The drug costs on average $8,000 per month.
Proponents of Avastin, the brand name for the drug bevacizumab, urged the FDA in emotional testimony this week not to remove the breast cancer indication from the label citing cost and their ability to pay for the drug as major factors in their continued care.
Priscilla Howard, a triple negative metastatic breast cancer patient who has been using the drug for 32 months along with Alerta, says the Avastin has worked for her. She testified although she is not cancer free, the disease has not progressed. In fact, she said, there is no evidence of the original tumor under her arm and there has been reduction in her lung tumors.
“My oncologist chose these drugs knowing that others, including the carbopatent, showed greater toxicity and would not be as effective or appropriate for my triple negative cancer,” she said.
In 2008, FDA granted accelerated approval to Avastin as initial treatment for HER2 negative metastatic breast cancer.