14/04/2026 FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma FDA sBLA Submission & NCCN Guideline Inclusion for BIZENGRI in NRG1 Fusion–Positive Cholangiocarcinoma Obsidian Therapeutics and Galera Therapeutics Announce Merger Agreement to advance OBX-115 TIL Therapy FDA Grants Fast Track to Daretabart for High‑Risk Neuroblastoma (Ref) Renaissance Pharma's Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody, has received Fast Track status from the U.S.

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 mDOR

18/08/2025 Izalontamab brengitecan received the Breakthrough Therapy Designation by the US FDA for EGFR-mutated NSCLC (Ref) The US FDA granted the Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb's izalontamab brengitecan (EGFR x HER3 bispecific ADC) for the treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR TKI and platinum