Novartis Receives FDA Approval for Tevimbra in Non-Small Cell Lung Cancer

Novartis today announced that the FDA has approved Tevimbra (tislelizumab-jsgr) in combination with carboplatin and nab-paclitaxel for the first-line treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. In the Phase 3 RATIONALE-304 trial, Tevimbra plus chemotherapy demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy alone. The median PFS was 9.7 months for Tevimbra plus chemotherapy versus 7.6 months for chemotherapy alone. This approval provides patients with non-squamous NSCLC a new first-line treatment option.