Pallone Reacts To FDA's Decision on Avastin

Washington, D. C. – U. S. Rep. Frank Pallone, Jr., issued the following statement on Thursday in response to the decision by the Food and Drug Administration to withdraw approval of Avastin:

“I am deeply concerned about the Food and Drug Administration’s decision to begin to withdraw approval for bevacizumab, also known as Avastin, to be labeled for the treatment of metastatic breast cancer.

“On the same day that the FDA announced its decision to withdraw approval for Avastin, on the other side of the Atlantic Ocean, the European Medicines Agency (EMA) affirmed its approval of the use of the same drug for the same indication of breast cancer. The EMA found that “the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer.

“These divergent decisions from the EMA and the FDA will likely be very confusing for breast cancer patients, some of whom have experienced improvements associated with use of Avastin. These women, who may have no other treatment options, should continue to have access to Avastin, when medically appropriate.

“The decision from the FDA does not prohibit physicians from prescribing Avastin “off label” for women with breast cancer, and physicians can continue to use their medical judgment on the value of Avastin for certain women. Likewise, women should continue to consult with their doctors and health care providers about the most appropriate, individualized treatment plan for their illness. For some patients, physicians may determine that Avastin is the best course of care.”