Merus NV

Merus N.V. announced US FDA approval of Bizengri (zenocutuzumab-zbco), the first treatment for advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with NRG1 gene fusion, based on ORR and DOR. Continued approval contingent on confirmatory trials. Expected to be available to patients soon.

FDA grants accelerated approval to zenocutuzumab for advanced NSCLC and pancreatic adenocarcinoma with NRG1 gene fusion, based on eNRGy trial results. Zenocutuzumab is the first FDA-approved systemic treatment for these patients.

Merus' Bizengri (zenocutuzumab-zbco) receives FDA accelerated approval for treating advanced NRG1+ pancreatic adenocarcinoma and NSCLC, with ORRs of 40% and 33% respectively in eNRGy trial. Continued approval depends on confirmatory trials. Available as 20mg/ml IV injection, it carries warnings for embryo-fetal toxicity and other risks.

FDA granted accelerated approval for BIZENGRI, a targeted therapy for pancreatic adenocarcinoma patients with NRG1 gene fusion, emphasizing precision medicine and the importance of biomarker testing. The approval marks the first for systemic therapy in NRG1 fusion-positive pancreatic adenocarcinoma and NSCLC, with 40% of patients experiencing tumor shrinkage. Patients should discuss with their healthcare team and consider biomarker testing to determine eligibility.

The FDA approved Merus N.V.'s Bizengri (zenocutuzumab-zbco) for advanced unresectable or metastatic pancreatic adenocarcinoma or NSCLC with NRG1 gene fusion, post-prior systemic therapy. Bizengri, Merus's first approved drug, is based on the Biclonics technology platform, with indications granted under accelerated approval. Expected availability for patients is in the coming weeks, supported by data from the eNRGy trial showing ORR of 40% in NRG1+ pancreatic adenocarcinoma and 33% in NRG1+ NSCLC.

The FDA has approved zenocutuzumab (Bizengri) for advanced non-small-cell lung cancer (NSCLC) and pancreatic cancer with NRG1 fusion. This targeted antibody blocks HER2 and HER3, preventing fusion proteins from promoting tumor growth. It will be administered once every two weeks and is expected to be available soon. The drug showed efficacy in shrinking tumors in 33% of NSCLC patients and 40% of pancreatic cancer patients, with effects lasting up to 16.6 months. Side effects include muscle pain, tiredness, and potential harm to unborn babies.

The FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with advanced, unresectable, or metastatic NSCLC or pancreatic adenocarcinoma harboring an NRG1 gene fusion, marking the first systemic therapy approval for these conditions. Efficacy was assessed in the eNRGy study, showing ORR of 33% for NSCLC and 40% for pancreatic adenocarcinoma, with median DOR of 7.4 months and range of 3.7 to 16.6 months, respectively. Common adverse reactions include diarrhea, musculoskeletal pain, and fatigue. The recommended dose is 750 mg IV every 2 weeks.

Merus secures FDA approval for Bizengri, a bispecific antibody targeting HER2 and HER3 to treat NRG1-driven pancreatic and lung cancers. Indicated for previously treated advanced-stage patients, approval is based on ORR and DOR, with potential for further approvals contingent on confirmatory trials. Bizengri comes with warnings for embryo-foetal toxicity and other risks. Merus plans to launch the drug soon, addressing a critical unmet need for NRG1+ cancer patients.