China National Drug Administration approves Opdivo to treat NSCLC.-BMS

Bristol-Myers Squibb Company announced that the China National Drug Administration (CNDA) has approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations.

This is China’s first and only PD-1 inhibitor and is the only Immuno-Oncology (I-O) agent to demonstrate a survival benefit compared with chemotherapy, based on data from the pivotal Phase III CheckMate -078 trial, in which 90% of the patients enrolled were Chinese.