Merus N.V. announced on December 4, 2024, that the U.S. Food and Drug Administration (FDA) granted accelerated approval to BIZENGRI® (zenocutuzumab-zbco). This approval is for adults with advanced, unresectable, or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harboring an NRG1 gene fusion, who have progressed on prior systemic therapy.
BIZENGRI® is Merus's first approved medicine, validating its proprietary Biclonics® technology platform. The approval is based on data from the eNRGy trial, which showed an overall response rate (ORR) of 40% in NRG1+ pancreatic adenocarcinoma patients (n=30) and 33% in NRG1+ NSCLC patients (n=64).
This approval fills an important need for patients with NRG1+ cancer who previously lacked specifically targeted treatment options. BIZENGRI® is expected to be available to patients in the coming weeks, marking a significant commercialization milestone for Merus.
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