Regulatory briefs from Astellas, Janssen, Biogen and Elan, and QRxPharma

The US subsidiary of Japanese drug major Astellas Pharma  (TYO: 4503) says the US Food and Drug Administration has accepted for filing a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) activating mutations.

The application has been granted Priority Review status, and an FDA decision is expected in the second quarter of 2013. A pre-market approval application for a companion diagnostic, the cobas EGFR Mutation Test developed by Roche Molecular Diagnostics, has also been submitted to the FDA.

European Commission approves once-daily Prezista