Japan's 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, the company reported.
Erlotinib is the only compound as an EGFR tyrosine kinase inhibitor for which the survival benefit was proven with NSCLC. Positive results for the drug were demonstrated in a recent double-blind Phase III trial 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.
A Japanese Phase II study was also recently conducted to evaluate erlotinib's
efficacy and safety. The results confirmed erlotinib's antitumor effect and
tolerability in patients after failure of prior chemotherapy regimens, including