Zenocutuzumab

MSKCC advanced cancer treatments in 2024 include new surgical techniques, vaccines, drugs enhancing radiation, and diagnostic tools. The FDA approved 11 drugs based on MSK's pivotal clinical trials, covering new uses for existing drugs, effective drug combinations, engineered cell therapies, and novel targeted therapies. Key developments include a KRAS vaccine for pancreatic and colorectal cancer, combination drug-radiation treatment for basal cell carcinoma, noninvasive E-nose for lung cancer detection, improved transplant success with partially matched donors, exercise impact on prostate cancer biomarkers, new imaging for lung and prostate cancers, TIL therapy for non-small cell lung cancer, robotic neurosurgery for spinal tumors, avoiding surgery for HPV throat cancer with innovative radiation, imlunestrant for ER+, HER2- advanced breast cancer, mRNA vaccine for pancreatic cancer, and immunotherapy for rectal cancer. FDA approvals included tepotinib for METex14 lung cancer, CAR T treatment for mantle cell lymphoma, selpercatinib for RET-linked thyroid cancer, repotrectinib for NTRK fusion cancers, adagrasib with cetuximab for KRAS-G12C colorectal cancer, afamitresgene autoleucel for synovial sarcoma, vorasidenib for IDH glioma, inavolisib with fulvestrant and palbociclib for breast cancer, revumenib for KMT2A leukemia, zanidatamab for HER2 biliary tract cancer, and zenocutuzumab for NRG1 fusion pancreatic and lung cancers.

Zenocutuzumab approved for NRG1+ NSCLC and PDAC; sacituzumab tirumotecan granted breakthrough status for EGFR+ NSCLC; durvalumab approved for limited-stage SCLC; sonodynamic therapy shows improved OS and PFS in recurrent glioblastoma; systemic therapy choice impacts brain metastases outcomes.

Jim Cramer discusses Merus N.V. (MRUS) under his lightning rounds spotlight, noting its speculative nature despite FDA approval for cancer therapy Bizengri. Cramer cautions against market complacency and overly optimistic expectations for Federal Reserve rate cuts, highlighting the potential for disappointment. MRUS ranks 3rd on the list, with AI stocks seen as more promising for higher returns.

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 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.

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.

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.