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CHMP recommends new indication for BMS’s Opdivo® (nivolumab) for NSCLC

May 26, 2023

Bristol Myers Squibb announced that the EMA CHMP recommended the approval of Opdivo® (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) with a high risk of recurrence in adult patients whose tumor cells express PD-L1 at a level of 1% or higher.  The recommendation is based on positive results from the CheckMate-816 trial, which demonstrated significant improvement in event-free survival and pathologic complete response when Opdivo® was combined with chemotherapy compared to chemotherapy alone prior to surgery.   

Opdivo® is already approved to treat melanoma, as an adjuvant treatment of melanoma, treat non-small cell lung cancer (with ipilimumab), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, as an adjuvant treatment of urothelial carcinoma, treat mismatch repair deficient or microsatellite instability-high colorectal cancer, oesophageal squamous cell carcinoma, as an adjuvant treatment of oesophageal or gastro-oesophageal junction cancer and treat gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma.  

In April 2023 BMS brought proceedings against AstraZeneca in the US District Court of Delaware claiming AstraZeneca’s Imfinzi® (durvalumab) infringed its patent encompassing Opdivo®