A first for Merus’ Bizengri with FDA nod

The US Food and Drug Administration (FDA) yesterday granted accelerated approval to Bizengri (zenocutuzumab-zbco; Zeno) from Dutch firm Merus NV (Nasdaq: MRUS), whose shares edged up 1.8% to $46.32 on the news.

The drug is now authorized for advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

The agency noted that this represents the first FDA approval of a systemic therapy for patients with NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion.