cancer drug Tarceva received regulatory approval for the additional use of treating patients with advanced pancreatic cancer.
The Food and Drug Administration approved the use of Tarceva -- which is currently on the market as a lung cancer drug -- in combination with gemcitabine chemotherapy for patients with advanced pancreatic cancer who haven't previously received chemotherapy.
The FDA based its approval on the results of a late-stage study of Tarceva used with gemcitabine chemotherapy in a group of patients with locally advanced, inoperable or metastatic pancreatic cancer. After one year of treatment, 24% of the patients receiving Tarceva plus gemcitabine were alive, compared with 19% of patients receiving gemcitabine and a placebo, the companies said.
Trial investigators also saw a significant improvement in survival without disease progression. And while there was little difference in the rates of tumor shrinkage between those receiving the Tarceva combo and those receiving gemcitabine alone, the disease control rate improved, Genentech and OSI said.
"Tarceva is the first FDA approved therapy in nine years to demonstrate an improvement in overall survival and we are pleased that pancreatic cancer patients now have a new treatment option with a proven survival benefit," said Gabe Leung, president of the oncology division at OSI, in a press release.
OSI also said that
, its marketing partner outside the U.S., has submitted an application to market the drug in Europe for the treatment of pancreatic cancer.
OSI and Genentech plan to continue studying Tarceva for use in other types of cancer and in combination with other treatments.
Genetech shares were up 5 cents to $91.80 in after-hours trading. OSI shares rose 11 cents to $23.84 after closing the regular session up 6.5%.