AstraZeneca PLC and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for use in patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant treatment and are at high risk of recurrence. The designation is based on positive results […]
Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival […]
Biohaven Ltd. presented updated Phase 1 clinical data on BHV-1510, its next-generation Trop2-targeting antibody-drug conjugate, at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress in London. The results, derived from a heavily pretreated population with advanced or metastatic solid tumors, showed encouraging response rates across non-small cell lung cancer, endometrial cancer, and urothelial […]