Zenocutuzumab

Zenocutuzumab, approved by FDA for NRG1 fusion cancers, targets HER2/3 proteins to inhibit tumor growth. Promising in trials, it reduces tumor size in NSCLC and pancreatic cancer. Side effects include muscle pain, fatigue, and nausea. Further trials needed for long-term benefits confirmation.

AstraZeneca and Daiichi Sankyo's cancer drug dato-dxd showed tumor control for 6 months in EGFR-mutated lung cancer patients; Agenus plans 60% spending cut to focus on late-stage colorectal cancer immunotherapy; Amgen invests $1 billion to expand NC manufacturing; USPTO withdraws proposed rule on preventing 'patent thickets'; Bluebird bio to undergo reverse stock split; FDA grants accelerated approval to Merus' zenocutuzumab for NRG1-altered lung and pancreatic cancers.

Merus NV received accelerated U.S. FDA approval for Bizengri (zenocutuzumab), the first targeted therapy for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease.

FDA granted accelerated approval to zenocutuzumab (Bizengri®) for advanced pancreatic cancer or non-small cell lung cancer with NRG1 gene fusion, based on a phase 2 trial led by MSK's Dr. Alison Schram. The trial showed 40% response rate in pancreatic cancer and 33% in NSCLC, with mild side effects. Meryl Jacobs, a pancreatic cancer patient, benefited from the treatment, attributing MSK for saving her life.

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.

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 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.

FDA approves zenocutuzumab-zbco for advanced NSCLC or pancreatic cancer with NRG1 fusion, based on eNRGy trial data showing ORR of 42.4% in pancreatic and 37.2% in NSCLC patients. Zenocutuzumab offers a new treatment option for NRG1 fusion–positive cancers, addressing poor prognosis and limited options.

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.