May 14 U.S. health regulators on Tuesday
approved a test developed by Roche for a specific gene
mutation present in about 10 percent of non-small cell lung
cancers, and said the company's drug Tarceva could be used as an
initial treatment in patients with the mutation whose cancer has
spread beyond the lungs.
This marks the first companion diagnostic that detects
epidermal growth factor receptor (EGFR) gene mutations to be
approved by the U.S. Food and Drug Administration, the agency
said. The diagnostic is called the Cobas EGFR Mutation Test.
"Companion diagnostics play an important role in determining
which therapies are the safest and most effective for a
particular patient," Alberto Gutierrez, of the FDA's Center for
Devices and Radiological Health, said in a statement.
The approval will also move Tarceva up the treatment chain
for those patients who test positive for the EGFR mutation. The
drug was originally approved in patients with advanced non-small
cell lung cancer only after they were not helped by at least one
previous chemotherapy regimen.
"People with this type of lung cancer now have the option to
use a personalized medicine as their initial treatment to help
them live longer without their disease worsening," Hal Barron,
chief medical officer of Roche Holding Ag's Genentech unit, said
in a statement.