Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC.
FDA Feedback
The FDA cited inadequate representation of U.S. patients and standards of care in the Rationale-303 study, which lacked U.S. trial sites. CEO Vas Narasimhan acknowledged, “The data didn’t reflect the U.S. population in terms of patient numbers and care protocols.”
Development Shift
Tislelizumab, co-developed by Novartis outside China in a $2B+ deal, remains under FDA review for second-line monotherapy in esophageal squamous cell carcinoma (ESCC). A filing for first-line ESCC combination therapy is expected once sufficient U.S. data is gathered.-Fineline Info & Tech
