Medical Concern About FDA Approval Of Genentech (DNA) Avastin

February 24, 2008 by Douglas A. McIntyre

The FDA has approved Genentech’s (NYSE: DNA) drug Avastin for the treatment of breast cancer. The product is already Genentech’s top selling drug but is marketed for treating other cancers.

Tests by FDA science panels found that the drug does shrink tumors but does not extend patient life expectancy. "All they had was progression-free survival in one trial, no increase in quality of life and patient deaths in the Avastin group," said Fran Visco president of the National Breast Cancer Coalition. "We’re very confused why FDA made this decision, told MSNBC.

Genentech may be taking a product liability risk, which is not necessarily good for its shareholders. In the trial study of the drug which was submitted to the FDA "six deaths attributed to the drug."

Genentech had better hope that those causalities were an aberration.

Douglas A. McIntyre

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