FDA Adds 2 Warning Labels To Genentech Cancer Drug Avastin
The Food and Drug Administration has added two additional warning labels to Genentech Inc.'s (DNA) blockbuster cancer drug Avastin.
The new labeling warns of cases of a rare brain condition that may lead to blindness as well as the side effects of developing holes in the nose.
Genentech, in a letter to doctors, said the rare brain condition, called reversible posterior leukoencephalopathy syndrome, occurred at a rate of less than 0.1%. Earlier this year, the New England Journal of Medicine reported that two women developed RPLS while on Avastin. They recovered from the condition.
In the same letter, Genentech also said seven cases of nasal septal perforation, or holes in the nose, have been reported in the post-marketing setting.
Avastin was approved by the FDA in February 2004 as a treatment for colorectal cancer in combination with chemotherapy and has quickly become a big seller. Last year, Avastin generated U.S. sales of $1.13 billion, more than double the year before. Swiss drug company Roche Holding AG (RHHBY), which owns a majority of Genentech, markets Avastin outside the U.S.