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FDA Approves BIZENGRI® for NRG1+ Pancreatic Cancer and NSCLC

NextEdge Admin

05 Dec 2024

2 min 32 sec

Merus,NSCLC,pancreatic adenocarcinoma,FDA

Merus N.V. , a clinical-stage oncology company, announced FDA approval of BIZENGRI® (zenocutuzumab-zbco), the first treatment for adults with advanced unresectable or metastatic pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) harboring neuregulin 1 (NRG1) gene fusions. Approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR), continued approval is contingent on confirmatory trials. BIZENGRI® carries warnings for embryo-fetal toxicity, infusion-related reactions (IRRs), hypersensitivity, interstitial lung disease (ILD), and left ventricular dysfunction.

The approval, supported by data from the eNRGy trial, addresses an unmet need for NRG1+ cancers. In pancreatic adenocarcinoma patients (n=30), BIZENGRI® showed an ORR of 40% and a DOR ranging from 3.7 to 16.6 months. In NSCLC patients (n=64), ORR was 33% with a median DOR of 7.4 months. Common adverse reactions included diarrhea, musculoskeletal pain, fatigue, and nausea. The most frequent severe laboratory abnormalities were elevated liver enzymes and decreased hemoglobin, sodium, and platelets.

Dr. Alison Schram of Memorial Sloan Kettering highlighted the meaningful outcomes observed in the eNRGy trial. Shannon Campbell, Merus’s Chief Commercial Officer, emphasized the significance of this milestone, achieved through their proprietary Biclonics® platform, which also supports their pipeline, including lead candidate petosemtamab.

The Personalized Medicine Coalition lauded BIZENGRI®’s approval as a significant advancement in targeted therapies for difficult-to-treat cancers. Merus plans to assist patients through PTx Assist™, offering educational resources, insurance guidance, and financial support.

BIZENGRI® 20 mg/mL Injection is expected to be available soon, providing a new option for patients with NRG1+ cancers who have progressed on prior therapies.