Bristol Myers 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 Expre…
We see so many patients with resectable lung cancer. CHECKMATE 816 led to the approval of neoadjuvant nivolumab + chemo due to increased pathologic CR rates. The product is only approved for PD-L1 over 1% in Europe unlike all comers by the FDA. Should we really give it to all? Trial design has limitations, financial toxicity is real, and patient toxicity is real.