Genentech reports 36 cases of adverse reactions following bevacizumab injections in Canada

Genentech issued a letter to physicians last week informing them of 36 cases of intraocular adverse reactions following the off-label use of intravitreal bevacizumab reported by four locations in Canada. F. Hoffmann-La Roche, the company's global distribution partner, has identified 32 of these cases as serious inflammatory reactions, the letter said.

Twenty-five cases occurred in patients who were administered intravitreal Avastin (bevacizumab) from a single batch — lot B3002B028. However, a review of adverse event reports for patients who received intravenous bevacizumab from this lot did not reveal any unusual reporting patterns, and batch samples were found to have met all quality specifications for approved intravenous use of the drug.

"At this time, the cause of the cases in Canada is unknown," Genentech spokesperson Krysta Pellegrino told Ocular Surgery News via e-mail. "We have no evidence to suggest there are any implications for the approved uses of Avastin in oncology, or to suggest there is an increased risk of serious eye inflammation with Lucentis."

"Patient safety is a priority at Genentech, and we routinely monitor the safety of our products," she said. "Genentech decided to issue the [dear healthcare provider letter] so that physicians and patients are informed and aware of this important safety information when making treatment decisions.

She noted that bevacizumab is "manufactured, formulated, packaged and FDA-approved specifically for IV use for certain types of cancer." In addition, no large, clinical trials of the drug for ocular use have been completed, and "its safety and efficacy profile in this setting remains unknown."

All adverse events were reported to Roche between Nov. 4 and Nov. 20, the letter said.

Genentech asks that physicians report any serious adverse events suspected to be associated with the use of bevacizumab to Genentech Drug Safety at 888-835-2555.