15/10/2026 US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors Revolution Medicines' RASONQUE receives positive CHMP opinion for Metastatic Pancreatic Cancer US FDA grants second Fast Track Designation to Invikafusp Alfa in checkpoint-refractory TMB-High solid tumors (Ref) Marengo Therapeutics announced that the US FDA has granted a second Fast Track Designation (FTD) to Invikafusp alfa (STAR0602; bispecific dual T-cel

14/09/2026 US FDA reduces IMDELLTRA monitoring time to 6–8 hours, expanding Community Oncology Access BioNTech & Onco4's gotistobart doubled mOS vs docetaxel in non-pivotal part of the Ph3 PRESERVE-003 trial US FDA grants Breakthrough Therapy Designation to RASONQUE™ (daraxonrasib) + chemotherapy for first‑line metastatic pancreatic cancer In the Ph3 DESTINY-Lung04 trial, trastuzumab deruxtecan improved median PFS by 6 months vs pembro + chemo, in 1L HER2-mutant NSCLC pts Pos