Officials with Genentech Inc., the South San Francisco company that makes Avastin, expressed disappointment with the FDA's action but said a new Phase 3 clinical trial would begin soon to further evaluate how the medication works with paclitaxel. In addition, research will proceed on the search for biomarkers that may indicate whether a particular woman is likely to benefit from the drug.
Some researchers said they still believed it may help certain subgroups of women with breast cancer, such as people with so-called triple-negative disease, which is a particularly aggressive form.
"This is definitely not the end of the story for Avastin and breast cancer," said Dr. Neal Meropol, chairman of the American Society of Clinical Oncology's comparative effectiveness research task force and an oncologist at University Hospitals Case Medical Center in Cleveland. "It's quite likely there is a subset of patients who benefit from Avastin to a major degree. The challenge for us is to identify which patients with breast cancer will benefit."
But Meropol said that he agreed with the FDA's decision and applauded the time and diligence the agency gave in weighing the matter.