Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo with Chemotherapy By Investing.com

Bristol Myers (NYSE:) Squibb Receives Positive CHMP Opinion Recommending Approval for Opdivo (nivolumab) with Chemotherapy as Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer at High Risk of Recurrence in Patients with Tumor Cell PD-L1 Expression ≥1%

Bristol Myers Squibb (BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.

“The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to reduce the risk of disease recurrence, progression and death in resectable NSCLC when given before surgery. The CHMP’s recommendation moves us another step closer to addressing the pressing need to offer certain patients in the European Union a chance to change the course of their disease with an effective and tolerable pre-surgical option that may help reduce the risk of relapse.”

The positive opinion is based on results from the CheckMate -816 trial, which demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) with three cycles of Opdivo in combination with chemotherapy compared to chemotherapy alone when given before surgery. The safety profile of Opdivo with chemotherapy was consistent with previously reported studies in NSCLC. Primary analyses of pCR, EFS and preliminary overall survival (OS) data from CheckMate -816 were previously presented at medical congresses and published in the New England Journal of Medicine. Three-year data demonstrating durable clinical benefits with the combination were presented at the European Lung Cancer…