24/11/2025 Avenzo Therapeutics' AVZO-103 received the FDA fast track designation for metastatic urothelial cancer ( Ref ) The US FDA granted the fast track desingation to Avenzo Therapeutics' AVZO-103 (Nectin4/TROP2 bispecific antibody-drug conjugate) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received enfortumab vedotin. Mohammad Hirmand, M.D., Co-founder and Chief Medical Officer, Avenzo Therapeutics: “ Rece

11/11/2025 Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL ( Ref ) The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Yan Moore, CEO, Allterum Therapeutics: " The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and fami

03/11/2025 Iovance's lifileucel TIL therapy elicited an ORR of 25.6% in previously treated non-sq NSCLC ( Ref ) Iovance Biotherapeutics reported interim data from its registrational Phase 2 IOV-LUN-202/NCT04614103 trial of lifileucel monotherapy (autologous TIL therapy) in patients with previously treated advanced non-squamous NSCLC without actionable genetic mutations. An ORR of 25.6% (CR: 5.1%) was achieved in a pool of 39 patients At a median follow up of 25.4 mos, the mDO

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved  Jazz Pharmaceuticals ' lurbinectedin (DNA alkylating agent) +  Roche 's...