The tablets are used for the initial treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test.
The Agency has also approved the cobas EGFR Mutation Test, which was developed by Roche and validated in the pivotal Eurtac study.
Genentech Global Product Development head and chief medical officer Hal Barron said that 10% to 30% of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations.
"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," Barron added.
Astellas Pharma chief medical officer Sef Kurstjens said, "With this approval, more patients across all lines of therapy have access to Tarceva."