EU approves Opdivo (nivolumab) for squamous NSCLC- BMS + Ono
BMS has announced that the European Commission has approved nivolumab (Opdivo) for the treatment of locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy. This approval marks the first major treatment advance in squamous NSCLC in more than a decade in the European Union (EU). Nivolumab is also the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival (OS) benefit in previously-treated metastatic SQ NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU.
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.
Comment: Other PD (programmed death) antagonists in development include MEDI 4736 (durvalumab) from MedImmune/AstraZeneca and MPDL 3280A (atezolizumab) from Genentech/Roche, both of which are in Phase III studies, and Keytruda (pembrolizumab) from Merck Inc. which is now filed at the FDA.
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