CHUGAI FILES NDA FOR ERLOTINIB IN JAPAN

Chugai Pharmaceutical has filed a new drug application (NDA) for erlotinib for advanced or recurrent non-small cell lung cancer (NSCLC) with the Japanese Ministry of Health, Labor and Welfare.

Erlotinib is the only compound as an EGFR tyrosine kinase inhibitor for which the survival benefit was proven with NSCLC. This was demonstrated in a global double-blind Phase III trial (BR.21) conducted by the National Cancer Institute of Canada Clinical Trials Group, in which patients with locally advanced or metastatic NSCLC after failure of prior chemotherapy regimen were examined.