US FDA to halt breast cancer use for Roche's Avastin, but EMA says it's OK in combo with paclitaxel; no immediate somatropin concerns

The US Food and Drug Administration yesterday said that it is recommending removing the breast cancer indication from the label for Swiss drug major Roche (ROG: VX) subsidiary Genentech’s best-selling cancer drug Avastin (bevacizumab), because it has not been shown to be safe and effective for that indication, although the same day the European Medicines Agency decided that the product should remain an option in combination with paclitaxel.

The FDA’s decision does not impact Avastin’s availability for its approved uses for other cancer types in the USA.

“We are pleased that the EMA has confirmed the benefits of Avastin with paclitaxel and that Avastin will continue to be available for women with metastatic breast cancer living within the European Union,” said Hal Barron, chief medical officer and head, Global Product Development at Genentech. “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA,” he added.