MD Anderson Cancer Center and Nexo Therapeutics have entered a multi-year strategic collaboration that aligns the technology and capabilities of each organization at the earliest stages of drug discovery and development, with the aim of advancing cancer therapies against previously undruggable targets.
FDA has approved quizartinib (Vanflyta) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test.
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.
