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GEN News Highlights : Jul 21, 2010

FDA Panel Says Nay to Full Approval of Avastin in Her2-Negative Breast Cancer

Roche shares hit 52-week low, and final decision is expected by mid-September.

Roche’s Genentech confirmed that FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12–1 in favor of retracting Avastin’s existing provisional endorsement as first-line therapy combined with paclitaxel against advanced Her2-negative breast cancer. FDA is expected to make a final decision on whether to rubber stamp the committee’s recommendation by September 17.

Genentech admits that it is “disappointed by the ODAC conclusion” and says that it will continue to discuss data from the three relevant Phase III Avastin studies. “We believe Avastin should be an option for women with this incurable disease,” stresses Sandra Horning, M.D., Genentech’s svp and global head of clinical development hematology/oncology. The firm also points out that whatever the outcome, the U.S. ruling will not impact Avastin’s sanctioned uses for other cancer types or affect any approvals in other countries.

News of the ODAC’s recommendation caused Roche’s shares to slide 4.2% on the previous day’s close, effectively hitting a 52-week low and hovering at about the CHF 135–137 mark as the day’s announcement took its toll.

Avastin’s use in the U.S. as first-line combination therapy for Her2-negative breast cancer was sanctioned in February 2008 under FDA’s accelerated approval program. The decision was based on data from the Phase III E2100 study demonstrating an improvement in progression-free survival (PFS), Genentech explains. In November last year the firm submitted two sBLAs to FDA based on the Phase III Avado and Ribbon 1 trials, as part of its push to convert the accelerated approval to full approval. The two studies evaluated Avastin in combination with either docetaxel chemotherapy or with a taxane, anthracycline-based or capecitabine chemotherapy in women with advanced, previously untreated Her2-negative breast cancer.

Avastin was first approved for the treatment of breast cancer by the EMEA in combination with paclitaxel for first-line therapy of advanced Her2-negative disease in 2007. In July 2009, the approval was expanded to include Avastin in combination with docetaxel.

Avastin is currently approved in major markets including the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small-cell lung cancer, and kidney cancer. The drug is also available in the U.S. for the treatment of patients with advanced brain cancer.

As Roche’s top-selling drug in 2009, Avastin made sales of CHF 6.2 billion (some $5.9 billion), up 21% on 2008 in local currencies, and representing 16% of overall sales.