A research team at UVA Health is testing the ability of focused ultrasound to increase the immune response to immunotherapy in melanoma. UVA’s work with focused ultrasound already has led to life-changing new treatments for Parkinson’s disease and essential tremor and pushed the technology to the forefront of medical research.
A group of investigators led by Cedars-Sinai have developed and successfully tested a new artificial intelligence method to make launching cancer clinical trials easier and faster. The method uses patients’ pathology reports to automate the classification of patients by the severity of their cancers, potentially shortening the process of selecting candidates for clinical trials.
One-third of HER2-positive tumors express the P95HER2 protein, which associates with an aggressive form of breast cancer with a poorer prognosis. Investigators of the Vall d’Hebron Institute of Oncology’s Growth Factors Group, in collaboration with researchers of the Cancer Research Program of Hospital del Mar Research Institute, Barcelona, have developed novel chimeric antigen receptor T-cell therapy that can produce a potent antitumor response against p95HER2-expressing cells.
A new treatment approach developed at Roswell Park Comprehensive Cancer Center has shown promising results in a phase I clinical trial for patients with triple-negative breast cancer, the most aggressive type of breast cancer. Results of the study are newly reported in The Journal for ImmunoTherapy of Cancer.
Scientific progress often follows a prolonged path, but bioentrepreneur Samy Lamouille believes his dedication toward this pursuit will ultimately pay off for brain cancer patients.
FDA recently approved Alternative Standard #25 related to the Mammography Quality Standards Act. Alternative Standard #25 allows the interpreting physician to provide an assessment of “Incomplete: Need additional imaging evaluation” for the follow-up report issued within 30 calendar days of an initial report that received an assessment of “Incomplete: Need prior mammograms for comparison.”
FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older.
FDA accelerated approval of Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer, as detected by an FDA-approved test. Ziihera was approved under accelerated approval based on a 52% objective response rate and a median duration of response of 14.9 months as determined by independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The phase III HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.
FDA has accepted Bayer’s supplemental new drug application for the oral androgen receptor inhibitor Nubeqa (darolutamide) in combination with androgen deprivation therapy for the treatment of patients with metastatic hormone-sensitive prostate cancer.
FDA has approved FoundationOne Liquid CDx to be used as a companion diagnostic for Tepmetko (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Tepmetko received accelerated approval from FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations. FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for Tepmetko.
