Roche submitted a Marketing Authorisation Application to the European health authorities for its new cancer drug Tarceva (erlotinib) for the treatment of advanced non-small cell lung cancer (NSCLC).
The EU filing is based on results of the pivotal Phase III randomised trial (BR21) involving 731 patients, which compared the use of Tarceva versus placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly longer than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42 per cent. The study also met all of its secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate. In addition, there was a 45 per cent improvement in survival at one year and further analysis showed treatment benefit over a broad spectrum of patients, a company release says.
"The benefits of Tarceva in this patient group are very compelling. Tarceva represents the first significant advance in survival, among targeted therapies, for lung cancer patients who have failed available chemotherapy. In the study, one out of three patients on Tarceva was alive at one year as opposed to only one of five in the placebo group. We will work closely with regulatory authorities to bring Tarceva to patients as quickly as possible," said William M Burns, Head of Roche Pharmaceuticals Division.
Lung cancer is the most common cancer worldwide, accounting for 1.2 million new cases annually2 with someone, somewhere dying of lung cancer every 30 seconds.3 NSCLC accounts for almost 80 percent of all types of lung cancer and has few treatment options.
Tarceva is the first and only EGFR-targeted anticancer treatment to have shown a significant survival prolongation in lung cancer. An application for approval of Tarceva in advanced NSCLC was also filed with the US FDA this month, the release added.
Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers.