Merus N.V. (MRUS) announced that the U.S. Food and Drug Administration has granted accelerated approval for BIZENGRI (zenocutuzumab-zbco). This drug is the first and only treatment for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) that harbor a neuregulin 1 (NRG1) gene fusion. The approval is specifically for patients who have experienced disease progression following prior systemic therapy.
Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
BIZENGRI has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.
BIZENGRI (zenocutuzumab-zbco) 20 mg/mL Injection for Intravenous Use is expected to be available to patients in the coming weeks.
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Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.