The FDA commissioner, Margaret A. Hamburg, MD, has revoked the approval of Avastin (bevacizumab; Genentech) for the treatment of breast cancer after concluding that the drug has not been shown to be safe and effective for that use.
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The FDA is alerting healthcare professionals that repackaged intravitreal injections of Avastin (bevacizumab; Genentech) have caused a cluster of serious eye infections in the Miami area.
Genentech announced that during a FDA hearing, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated, first-line HER2-negative metastatic breast cancer.
The FDA has granted a hearing to allow Genentech the opportunity to present its views on why Avastin (bevacizumab) should remain FDA-approved for metastatic breast cancer.
The FDA has announced that it is recommending the removal of the breast cancer indication from the label for Avastin (bevacizumab, from Genentech) because the drug has not been shown to be safe and effective for that use.
Genentech is warning healthcare providers of 36 reports of intraocular adverse events following the off-label intravitreal use of Avastin (bevacizumab) injection.