CHMP recommends Opdivo (nivolumab) for metastatic squamous NSCLC-BMS
Bristol-Myers Squibb Company has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.
The CHMP positive opinion is based on data from CheckMate -017 and CheckMate -063, two trials that demonstrated the efficacy and safety of nivolumab in patients with advanced or metastatic squamous NSCLC who had progressed following previous chemotherapy treatment.
Comment: Nivolumab's mechanism of action means it is able to exploit the body's own immune system and initiate an anti-tumour immune response by targeting PD-1, a biomarker with high expression across many tumour types, therefore giving the drug the potential to be a blockbuster new NSCLC therapy.
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