Tarceva (erlotinib) is an oral tablet indicated for daily administration developed by OSI in collaboration with Genentech and Roche. It will now be available to patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Canada.
The drug is already approved in the US and Switzerland. The European Committee for Medicinal Products for Human Use has also recommended approval of Tarceva for the treatment of patients with advanced NSCLC. An approval decision by the European Commission is expected to come within the next few months.
The Canadian approval is based on data from a pivotal phase III study which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy.
The pivotal study included 731 patients with advanced NSCLC for whom one or more chemotherapy regimens had failed. Tarceva demonstrated a survival benefit in essentially all subsets of patients examined.
Median and one-year survival of the overall population in the BR.21 study was improved by 42.5% (6.7 versus 4.7 months) and 45% (31.2 versus 21.5%), respectively, and patients were treated with Tarceva for an average of just over four months in the study (23% of patients were on therapy for more than six months)
News of the Canadian approval caused OSI’s stock to gain 2.2%, forcing the price up to $46.23.