By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Genentech Inc. (DNA) has informed physicians about reported side effects related to off-label usage of cancer drug Avastin to treat a form of vision deterioration.
In treating the condition, some doctors use Avastin instead of Lucentis, sold by Genentech in the U.S. and Novartis AG (NVS) in Europe, because of a sharp price difference. The result has significantly slowed the growth of Lucentis, which did see third-quarter sales rise 14% to $225 million.
In the letter, Genentech said there were 36 cases of side effects, all in Canada, with 32 being serious inflammatory reactions inside the eye.
Most of the reports, 25, came from use of Avastin from the same manufacturing lot. The company said data from the lot shows that it met all quality specifications for use in cancer and that the cause of the cases is still unknown.
"We don't have any evidence to suggest that it is the Avastin," said Genentech spokeswoman Krysta Pellegrino. Genentech is majority owned by Roche Holding AG (RHHBY).
The reported problems occurred over 16 days in November at four sites, with 25 reports coming from two sites.
Genentech said this is the ninth cluster worldwide of side effects related to Avastin's use in the eye, but it is the largest yet reported and the first to result in a letter to physicians.
Lucentis is approved by the Food and Drug Administration to treat wet age-related macular degeneration in the eye, while Avastin is approved to treat advanced breast, lung and colorectal cancer. Once allowed on the market, doctors can prescribe a drug as they see fit.
Lucentis is molecularly similar to Avastin and works in a similar manner, but it costs about $1,950 a dose, while a comparable amount of Avastin is about $40.
In the past, Genentech has asserted that Lucentis is fundamentally different because it binds more tightly to its target because of limited space available within the eye.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
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Publié le 19 Décembre 2008 Copyright © 2008 Dowjones