Memorial Sloan Kettering Cancer Center

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.

St. Elizabeth Cancer Care, led by Dr. Douglas Flora, has evolved significantly, attracting top oncologists and specialists from renowned institutions. The program's success is attributed to its collaborative culture, advanced clinical trials, personalized medicine, and a comprehensive whole-person care model. The recent CMS 5-star rating underscores its commitment to excellence, enhancing recruitment and patient care.

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.

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.

Ryvu Therapeutics initiated the POTAMI-61 Phase II study evaluating RVU120's safety and efficacy in myelofibrosis patients, both as a single agent and in combination with ruxolitinib, based on positive RIVER-51 data and translational studies.

Zenocutuzumab-zbco (Bizengri; Merus NV) received FDA accelerated approval for adults with unresectable or metastatic NSCLC or PDAC harboring an NRG1 gene fusion, based on the eNRGy study results showing favorable ORR and DOR. This marks the first approved therapy for these conditions with an NRG1 gene fusion. The drug, a bispecific antibody targeting HER2 and HER3, demonstrated antitumor activity and safety in clinical trials.

Ryvu Therapeutics initiated POTAMI-61, a Phase II study evaluating RVU120's safety and efficacy in myelofibrosis (MF) patients, either as a single agent or combined with ruxolitinib. The study is based on RVU120's positive results from the RIVER-51 Phase I study in acute myeloid leukemia (AML) and translational data in MF, indicating potential for treating MF, including in patients unresponsive to JAK inhibitors. The POTAMI-61 study aims to reduce spleen volume, improve total symptom score, and decrease bone marrow fibrosis.

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