NEW YORK, Dec 19 (Reuters) - Genentech Inc DNA.N notified doctors of 36 cases of eye inflammation among patients who received injections with the company’s Avastin colon cancer drug for unapproved eye conditions.
Genentech, in a letter to healthcare providers,said its partner Roche Holding AG ROG.VX had informed it of the cases,which included 32 serious inflammatory reactions.
“These events were reported to Roche between November 4th and 20th, 2008, from four different reporting sites,” Genentech said.
Roche, which holds a majority stake in Genentech, markets Avastin for cancer in many markets outside the United States, including Canada.
Genentech sells Avastin in the United States for the treatment of lung and colon cancer. It also sells a similar drug called Lucentis, which is a fragment of the Avastin antibody, to treat a sight-endangering eye condition called wet macular degeneration.
Although Avastin is not approved to treat the eye condition, many doctors have divided it into multiple doses and used it instead of the more costly Lucentis. Such use is considered “off-label” and not formally approved by the U.S. Food and Drug Administration.
Genentech spokeswoman Krysta Pellegrino said 25 of the cases were from one lot of Avastin. A lot consists of 66,000 single-use vials. She said all quality specifications established for approved uses of Avastin were met.
About 2 percent of patients who receive Lucentis develop eye inflammation, Pellegrino said, adding Genentech does not know what percentage of patients receiving off-label Avastin develop such inflammation.
The U.S. National Institutes of Health is sponsoring a head-to-head trial comparing Avastin and Lucentis for macular degeneration.
Should the drugs show comparable safety and effectiveness, the U.S. government could shift patients in the Medicare insurance program to less costly small doses of Avastin. (Editing by Leslie Gevirtz)