The approval allows Roche to use Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations.
In previous studies, Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival – PFS) compared to chemotherapy.
Roche Global Product Development head and chief medical officer Hal Barron said the European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment.