BRIEF—Additional approval for Opdivo in Taiwan

Ono Pharmaceutical’s Taiwanese subsidiary has received the additional approval of Opdivo (nivolumab) intravenous infusion 20mg, 100mg Inj, a human anti-human PD-1 monoclonal antibody, from the Taiwan Food and Drug Administration (TFDA) for the first-line treatment of advanced or recurrent no-squamous non-small cell lung cancer with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations in combination with bevacizumab and chemotherapy.

This approval is based on the result from a Phase III TASUKI-52 study (ONO-4538-52), evaluating Opdivo in combination with bevacizumab and chemotherapy (Opdivo combination group), versus placebo in combination with bevacizumab and chemotherapy (control combination group) in chemotherapy-naïve patients with stage IIIB/IV or recurrent non-squamous non-small cell lung cancer (NSCLC) unsuitable for radical radiation.

In the interim analysis of this study, the Opdivo combination group demonstrated a statistically-significant improvement in the primary endpoint of progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRRC), compared to control combination group.