Genentech disappointed with FDA ODAC's recommendation against Avastin

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin's U.S. label. The committee's vote does not affect the current availability of Avastin for people with advanced HER2-negative breast cancer in the United States. The FDA is expected to make a decision on the first-line use of Avastin in combination with certain types of chemotherapy in the United States for advanced breast cancer by September 17, 2010.

"We are disappointed by the committee's recommendation and believe Avastin should be an option for women with this incurable disease," said Sandra Horning, M.D., senior vice president, global head, Clinical Development Hematology/Oncology. "We will continue to discuss the data from the more than 2,400 women who participated in three Phase III studies with the FDA. This recommendation does not impact Avastin's approved uses for other cancer types."

The recommendation also does not impact the use of Avastin for advanced breast cancer in other countries.

Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. This approval was based on results of the Phase III E2100 study and granted under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. The effectiveness of Avastin in advanced breast cancer is based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. Currently, there are no data available showing that Avastin improves disease-related symptoms or survival in HER2-negative advanced breast cancer.

In November 2009, the company submitted two supplemental Biologics License Applications (sBLAs) to the FDA based on the AVADO and RIBBON 1 studies as part of the company's effort to convert the accelerated approval to a full approval.

The ODAC reviewed data from all three studies (E2100, AVADO and RIBBON 1), which showed that Avastin plus commonly used chemotherapies (taxane-based, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the disease growing or spreading (PFS), compared to the chemotherapies alone. In these studies, adverse events were generally consistent with those previously reported for Avastin and no new safety signals were observed.

Across the studies, the most common adverse events associated with Avastin treatment were high blood pressure (10.4 percent vs. 1.2 percent) and proteinuria (2.6 percent vs. 0 percent). The incidence of severe adverse events known to be associated with Avastin treatment included arterial thromboembolic events (1.9 percent vs. 0.3 percent), bleeding (1.6 percent vs. 0.4 percent), febrile neutropenia (5.0 percent vs. 3.5 percent), fistula (0.4 percent vs. 0.3 percent), gastrointestinal (GI) perforation (0.5 percent vs. 0.3 percent), left ventricular systolic dysfunction (LVSD) (1.5 percent vs. 0.2 percent), neutropenia (8.0 percent vs. 7.1 percent), sensory neuropathy (9.7 percent vs. 8.5 percent) and venous thromboembolic events (3.0 percent vs. 3.8 percent). In clinical trials across cancer types, serious and sometimes fatal side effects in people given Avastin included gastrointestinal perforation, surgery and wound healing complications, and severe bleeding.

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