At the 2010 conference, Penn cancer researchers highlighted the promising results of targeted immunotherapy in treating metastatic breast cancer.
While there may have been no single big story, significant data were presented across the full platform of breast cancer-related topics: from prevention to neoadjuvant therapy and managing metastatic disease. Major emphasis was placed on improved understanding of the biology of breast cancer and the development of more targeted therapies tailored to match the specific genetic profiles of patients.
From the Headlines: FDA Approval for Bevacizumab
David M. Mintzer, MD
One issue that has been in the headlines during the past months is the status of FDA approval of bevacizumab (Avastin®) for first-line of treatment of HER2-negative metastatic breast cancer in combination with paclitaxel. Bevacuzumab received fast track approval in 2008. Subsequent studies, including those presented at ASCO 2011, demonstrated modest improvements in progression-free survival, but none in overall survival or improvement in disease-related symptoms. The down sides of the drug are its toxicity and high costs of administration.
Just hours after the update concluded, the Oncologic Drugs Advisory Committee voted 6-0 to withdraw FDA approval for bevacizumab for treating HER2-negative metastatic breast cancer. While the committee vote was unanimous, the hearing itself was marked by emotional pleas from breast cancer patients who believe they are benefitting from bevacizumab treatment. The recommendation is not binding and a final decision is expected in September. It also does not affect insurance coverage or availability at this time, or the drug's approval for other cancer types.
"We know this drug has activity in some women," said David Mintzer, MD, clinical associate professor and chief of hematology/oncology, Pennsylvania Hospital. "We have all seen it and we know that activity stops when you stop giving the drug, but we just know now how to predict which women will get that benefit."