Merus NV

FDA approves BIZENGRI®, first treatment for NRG1 gene fusion-positive advanced pancreatic adenocarcinoma and NSCLC, based on eNRGy trial data showing ORR of 40% and 33% respectively. Merus and Partner Therapeutics announce U.S. commercialization agreement.

FDA approves durvalumab for limited-stage small cell lung cancer and zenocutuzumab-zbco for advanced NSCLC and pancreatic adenocarcinoma with NRG1 gene fusion.

DelveInsight's HER2+ Gastric Cancer Market Insights, Epidemiology, and Market Forecast-2032 report details historical and forecasted epidemiology, market trends in the US, EU5, and Japan. Key companies include Roche, Elevar Therapeutic, Bristol-Myers Squibb, Merck, and Daiichi Sankyo. Therapies like SHR-A1811, Cinrebafusp alfa, and BI-1607 are highlighted. Regulatory approvals for KN026 and Enhertu are noted, with market growth expected due to increasing prevalence and pipeline product launches.

Merus receives FDA approval for Bizengri, a first-in-class therapy targeting NRG1 gene mutations in advanced pancreatic adenocarcinoma and NSCLC, with an objective response rate of 33% and 40% respectively. The approval is based on the eNRGy trial results and comes after Merus partnered with Partner Therapeutics for US commercialization. Bizengri carries a boxed warning for potential harm to unborn children.

The FDA approved Merus NV's therapy, Bizengri, targeting the NRG1 gene for hard-to-treat lung and pancreatic cancers. Bizengri is the first approved therapy for non-small cell lung cancer and pancreatic adenocarcinoma with NRG1 gene fusion, blocking HER3-NRG1 interaction to inhibit tumor growth. The recommended dose is 750 mg IV infusion every 2 weeks.

FDA approves Bizengri (zenocutuzumab-zbco) for NRG1+ pancreatic adenocarcinoma and NRG1+ non–small cell lung cancer, marking the first treatment targeting these conditions.

Merus announces FDA approval of Bizengri, the first treatment for advanced unresectable or metastatic pancreatic adenocarcinoma and non-small cell lung cancer in adults, based on the eNRGy trial and its Biclonics technology platform.

FDA granted accelerated approval to zenocutuzumab (Bizengri) for NRG1 gene fusion-positive pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). The therapy targets HER2 and HER3, addressing advanced, unresectable, or metastatic disease that progressed on prior systemic therapy. Results from the eNRGy study showed a third of NSCLC patients and 40% of pancreatic cancer patients responded, with median duration of response of 7.4 months and 3.7 to 16.6 months, respectively. Common adverse events included diarrhea, musculoskeletal pain, and fatigue.

Merus announces FDA approval of BIZENGRI® (zenocutuzumab-zbco) for NRG1+ pancreatic adenocarcinoma and NRG1+ NSCLC, based on eNRGy trial results showing 40% overall response rate in pancreatic cancer and 33% in NSCLC. The drug's duration of response ranges from 3.7 to 16.6 months in pancreatic cancer and 7.4 months in NSCLC. Approval is under the accelerated pathway, pending confirmatory trials, and BIZENGRI® is expected to be available to patients soon, with the PTx Assist™ program offering support.