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FDA Grants Accelerated Approval For Merus' BIZENGRI For Pancreatic Adenocarcinoma And NSCLC

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

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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Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.