BMS Receives Positive CHMP Opinion in the EU for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous NSCLC in Previously-Treated Patients

Bristol-Myers Squibb Company (BMS) 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 will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).

“We are moving at a ground-breaking pace to deliver on a mission that looks to transform cancer treatment options for patients,” said Michael Giordano, senior vice president, Head of Development, Oncology. “Last month, we received a CHMP positive opinion for nivolumab for the treatment of advanced melanoma. Today’s announcement of a positive opinion for nivolumab in NSCLC brings us closer to delivering on our promise of changing the standard of care for lung cancer.”