The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage 2B or 2C melanoma.
European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of conditional marketing authorization for Tepkinly (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. The final European Commission decision on this indication for Tepkinly is anticipated later this year.
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.Â
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.Â
Lifebit, gen-t, and Omica.bio have partnered to help diversify genomic research and reduce health inequality in Latin America.Â
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%.Â
FDA has established the Oncology Quality, Characterization and Assessment of Real-World Data initiative.
