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news.Tarceva, the anti-cancer agent developed by OSI Pharmaceuticals, Genentech and Roche, has received a positive opinion from an advisory panel to the European regulator for its use in locally advanced or metastatic non-small cell lung cancer.
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The European Committee for Medicinal Products for Human Use (CHMP) has recommended the anti-cancer drug for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Tarceva is an oral tablet indicated for daily administration and was approved in the US for non-small cell lung cancer (NSCLC) in November 2004. Following the CHMP recommendation, an approval decision for Tarceva by the European Commission is anticipated within 90 days.
The CHMP recommendation is based on supportive data from a pivotal phase III study, Trial BR.21, which compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy.
“The European Committee for Medicinal Products for Human Use recommendation is an important milestone toward making Tarceva available for lung cancer patients throughout the European Union,” stated Dr Colin Goddard, CEO of OSI Pharmaceuticals.