FDA requires several changes to bevacizumab label to include safety information

November 1, 2011

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

Key Points

Safety information changes to the package insert for bevacizumab (Avastin, Genentech) were issued by FDA on September 30, 2011. These changes included safety information regarding the risk of ovarian failure, venous thromboembolism (VTE), and bleeding in patients treated with anticoagulants after first VTE episode, and osteonecrosis of the jaw. Bevacizumab is currently indicated for the treatment of metastatic breast, renal cell, or colorectal cancer; non-squamous, non-small cell lung cancer; and glioblastoma.

New to the "Warnings and Precautions" section is a statement that urges women to be informed of the risk of ovarian failure with bevacizumab treatment. This stems from a sub-study of 179 women treated with mFOLFOX chemotherapy regimen plus bevacizumab versus mFOLFOX regimen alone for the treatment of stage 1 or 3 colorectal cancer (off-label use). The relative risk of ovarian failure in women receiving bevacizumab was 14% (95% CI, 4%– 53%) compared to women who did not receive bevacizumab. Ovarian function recovered in 23% of females who experienced failure.

In patients who were treated with bevacizumab for metastatic colorectal cancer, the incidence of first VTE was higher (13.5%) compared to patients without bevacizumab (9.6%). The incidence of a subsequent VTE in those patients who were treated with an anticoagulant was also increased in the bevacizumab group (31.5%) compared to those without bevacizumab treatment (25.6%), as was the incidence of bleeding (27.4% vs 20.9%). This data has been added to the "Clinical Trial Experience" section of the bevacizumab label.