FDA has granted Fast Track designation to Ambrx’s proprietary anti-PSMA antibody-drug conjugate investigational therapy, ARX517, for the treatment of patients with metastatic castration-resistant prostate cancer upon progression on an androgen receptor pathway inhibitor.
The European Medicines Agency accepted for regulatory review Astellas Pharma’s marketing authorization application for zolbetuximab, an investigational claudin 18.2-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
Lifebit, gen-t, and Omica.bio have partnered to help diversify genomic research and reduce health inequality in Latin America.
FDA has accepted and the Biologics License Application for zolbetuximab, a first-in-class investigational Claudin 18.2-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
The European Commission has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%.
FDA has established the Oncology Quality, Characterization and Assessment of Real-World Data initiative.
NCI has awarded LoxiGen Inc. a three-year Fast-track Small Business Technology Transfer grant to develop a drug that targets treatment-resistant triple-negative breast cancer.
FDA approved Talzenna (talazoparib) with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
FDA established a voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.
Flatiron Health is partnering with Leeds Teaching Hospitals NHS Trust, one of largest acute hospital trusts in Europe. “Alongside partners, regulators, and patient advocates—and with scalable and secure methods—Flatiron has developed a unique offering in the UK to translate data from routine clinical care into research-ready datasets,” Flatiron CEO Carolyn Starrett said in a statement.... […]
