Roche’s Tarceva (erlotinib) has received approval from the European Commission for use in patients with a type of non-small-cell lung cancer (NSCLC).
The European approval will enable its use as a first-line monotherapy in NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations following impressive Phase III data.
Hal Barron, Chief Medical Officer and Head, Global Product Development, says the approval is “good news for patients”.
Tarceva is already approved in Europe for use in advanced or metastatic NSCLC, irrespective of a patient’s EGFR status, both as maintenance therapy after initial chemotherapy, and in patients whose disease has progressed following at least one course of chemotherapy.
Data from the European Randomised Trial of Tarceva vs. Chemotherapy (EURTAC) demonstrated that the treatment is superior to chemotherapy in EGFR activating mutation positive NSCLC.
The trial found that Tarceva nearly doubled median progression free survival and more than tripled the response rate compared to chemotherapy.
“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,” said Hal Barron.