In something of a vindication for Genentech, the company announced 36 reports of inflammatory responses in Canadian patients using Avastin for the off-label treatment of wet age-related macular degeneration. Thirty-two of the infections were deemed serious. Though 25 of the adverse events occurred in patients using the same lot of Avastin, an analysis of that lot's release data found that "all quality specifications established for approved intravenous use of Avastin were met," the company said in a "Dear Healthcare Provider" letter.
As you know, Genentech has been warning against the ophthalmological use of Avastin, a cancer drug that pharmacists repackage into small vials for use in the eye. The company markets a wet AMD drug, Lucentis, but it's far more expensive than the reapportioned Avastin, so many patients and doctors had turned to the latter as a money-saving alternative. Lucentis' sales growth has slowed as a result; third-quarter sales for the drug amounted to $225 million.
The company has been trying to whittle down that off-label Avastin use, reminding docs and pharmacists that it's not FDA-approved. The drugmaker even tried to shut down some supply lines that led to ophthalmologists and their patients, but backed down--at least partway--when an outcry ensued.
Meanwhile, the feds are working on a study that would pit Avastin and Lucentis head-to-head in treatment of wet AMD. But results of that study won't be available for years.
- see Genentech's letter
- read the story from Dow Jones
- check out the Pharmalot post
Editor's Note: The story originally said Avastin was linked to eye infections; in fact, off-label use of the drug is reported to cause inflammatory responses in patients.