Roche Holding AG’s Tarceva medicine extended the time patients with a certain kind of newly diagnosed lung cancer lived without their disease getting worse in a late-stage study.
An independent committee recommended stopping the trial early because the drug was more effective than platinum-based chemotherapy in recently discovered, advanced non-small cell lung cancer in patients with a gene mutation called EGFR, Basel, Switzerland-based Roche said in a statement today.
Roche said it will now ask U.S. regulators to approve Tarceva as an initial treatment in patients with this type of cancer. The study, called Eurtac, was the first late-stage trial in a Western population with this form of lung cancer, Roche said. A similar study, Optimal, has been carried out in an Asian population. Tarceva, also known as erlotinib, won U.S. approval in 2004 to treat non-small-cell lung cancer and is also cleared for pancreatic tumors.
“The Eurtac study demonstrates that testing for EGFR activating mutations can identify people who may be candidates to receive Tarceva as their initial treatment for advanced lung cancer,” Hal Barron, chief medical officer at Roche, said in the statement.
Roche asked European regulators to extend the current label for Tarceva to include initial treatment of people with this form of the disease in June.
The medicine works by blocking a protein called epidermal growth factor that helps cancer cells spread. Roche said in November it’s developing a companion diagnostic test for Tarceva that will identify EGFR activating mutations. As many as 10 percent of lung cancer patients in the Western population and as many as 30 percent in Asian populations may have the mutation, Roche said.
The company is developing the medicine with OSI Pharmaceuticals Inc., which was bought in June by Astellas Pharma Inc., Japan’s second-largest drugmaker.