The Food and Drug Administration has extended the review period
for using the cancer drug Tarceva as a first-line treatment in
patients with advanced lung cancer, after the agency was given
additional data from OSI Pharmaceuticals Inc. (OSIP).
Tarceva--co-marketed by OSI and Roche Holding AG's (RHHBY,
ROG.VX) Genentech unit--is currently approved to treat non-small
cell lung cancer after chemotherapy has failed to stop the cancer's
spread. While the drug is considered a second-line therapy, the
companies want FDA approval to use Tarceva immediately after
chemotherapy, as a maintenance treatment in patients whose disease
is stable after chemotherapy.
Last month, an FDA panel of outside medical experts voted
against approval of Tarceva for that purpose. The FDA usually
follows its panel's advice but isn't required to.
On Friday, OSI and Genentech said they now expect FDA action on
the drug application by April 18. The companies plan to work
closely with the FDA during the extended review process.
Tarceva is an oral drug that blocks an enzyme involved with
cancer growth.
OSI shares were recently up 18 cents, or 0.5%, to $34.41.
-By John Kell, Dow Jones Newswires; 212-416-2480;
john.kell@dowjones.com
(Jennifer Corbett-Dooren contributed to this report)