Roche’s Tarceva (erlotinib) has been granted a European licence as a first-line monotherapy for patients with an advanced form of non-small cell lung cancer (NSCLC) with a certain mutation.
The licence is based on Phase III trials which showed Tarceva nearly doubled the time patients lived without their disease progressing compared with chemotherapy.
Dr Liz Toy, Royal Devon and Exeter Foundation NHS Trust, says the new indication is “exciting news” for patients who may have an “enhanced response” using the treatment.
Tarceva is already approved for use in the UK for patients with advanced or metastatic NSCLC, irrespective of a patient’s epidermal growth factor receptor (EGFR) status.
Data from the two Phase III studies, EURTAC and OPTIMAL, investigated patients with an EGFR mutation and demonstrated that Tarceva significantly increased the time patients live without the cancer progressing.
“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, Chief Medical Officer and Head, Global Product Development at Roche.
More than 39,000 new cases of lung cancer are diagnosed in Britain each year.