At the same time, the FDA said, the drug has "major safety issues," including hypertension, clotting events, left ventricular heart dysfunction, heart attack, gastrointestinal perforation and proteinuria (excess protein in urine). A special FDA staff review of the data found that rates of grades 3 to 5 toxicities rose by more than 20 percent when cancer patients received Avastin on top of regular chemotherapy.
Furthermore, in the Avastin-paclitaxel trial, the rate of patient deaths linked to Avastin use was 1.7 percent (six out of 363 users) compared to no deaths among the 348 participants who did not receive the drug, the FDA noted.
In its approval submission statement to the FDA, Genentech contended that, "Analysis of the safety and efficacy data in total demonstrates a highly favorable risk-benefit profile for bevacizumab in combination with paclitaxel that supports full approval of bevacizumab for the treatment of locally recurrent and metastatic breast cancer."
The FDA is not obligated to follow the recommendations of its advisory panels, but usually does. A decision is expected by Feb. 23, the AP reported.
Avastin is not traditional chemotherapy, but instead is a monoclonal antibody that robs tumors of their blood supply. It has been found to boost the survival of patients with metastatic colorectal cancer and non-small-cell lung cancer when added to chemotherapy and used as a first-line treatment.
But the drug has its downside. In an analysis of pooled data from five randomized controlled trials involving more than 1,700 patients with metastatic colon, breast or lung cancers, Genetech researchers found that 3.8 percent of patients experienced blood clots while on the drug, compared to 1.7 percent of those who took standard chemotherapy alone.
All rights reserved