FDA Grants Fast Track Designation to Next-Generation ADC Based on Phase I/II Trial Data
February 6th 2024The ongoing Phase I/II NCT05438329 trial is evaluating BNT325/DB-1305 in patients with platinum-resistant ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer previously administered one to three systemic treatment regimens.
Phase III Trial Data Leads to FDA Priority Review of sBLA for Expanded Indication of Arexvy for RSV
February 6th 2024The supplemental Biologics License Application for Arexvy was based on positive data from the Phase III NCT05590403 trial, which analyzed the immune response and safety of Arexvy in individuals 50-59 years of age with an elevated risk of respiratory syncytial virus-related lower respiratory tract disease.
Phase III EV-302 Trial Data Lead to sNDA Submission for Padcev/Keytruda Combo for Urothelial Cancer
January 31st 2024The Padcev/Keytruda combination produced statistically significant and clinically meaningful improvements to survival compared to platinum-containing chemotherapy in first-line treatment of adults with previously untreated locally advanced or metastatic urothelial cancer.