Roche’s Tarceva approved in Europe for NSCLC

Roche has received approval from the European Commission for its drug Tarceva to be used to treat a specific form of non-small cell lung cancer (NSCLC).

The product has been ratified as a first-line monotherapy in people with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EFGR)-activating mutations.

This form of the disease has been shown in clinical trials to be particularly susceptible to Tarceva, with use of the drug tripling the response rate among patients and offering improved progression-free survival rates compared to chemotherapy.

Dr Hal Barron, chief medical officer and head of global product development at Roche, 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."

Tarceva is already approved as a maintenance therapy for NSCLC, regardless of EFGR status.

Last month, the UK's National Institute for Health and Clinical Excellence requested that Roche provides more data to assist the regulator's decision to recommend RoActemra as a systemic juvenile idiopathic arthritis therapy.