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

(RTTNews) - 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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