EMA validates application for Opdivo (nivolumab) to treat non-squamous NSCLC - BMS
The EMA has validated Opdivo (nivolumab) from BMS, as monotherapy, for a variation application to extend the current indication for Opdivo for non squamous lung cancer. The type II variation submitted to the EMA in non-squamous NSCLC is supported by data from the landmark, global Phase III study, CheckMate -057, which evaluated the survival of patients with advanced non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.
Comment: The European Commission approved Opdivo, for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer after prior chemotherapy on 20 July 2015
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