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

31/08/2026 MT027 secures US FDA Fast Track designation for recurrent Glioblastoma FDA clears IDEAYA’s IDE849 Phase 3 path in ES-SCLC In Phase 3 HERIZON-GEA-01 trial, ZIIHERA + chemotherapy demonstrated a statistically significant improvement in OS vs trastuzumab + chemotherapy, meeting the primary endpoint ORPATHYS + TAGRISSO® demonstrated significant PFS benefit with early OS signal in first-line EGFRm NSCLC with MET overexpression Karyopharm files sNDA for selinexor + ruxol

03/08/2026 US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer FDA Grants Orphan Drug Designation to DLL3-Targeting ADC Zoci, for Neuroendocrine Carcinomas US FDA grants Breakthrough Therapy designation to Lilly’s olomorasib for KRAS G12C-mutant pancreatic cancer (Ref) Eli Lilly announced that the US FDA has granted Breakthrough Therapy designation to olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant a

11/05/2026 FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs Hansoh Pharma’s HS-20093 B7-H3 ADC wins NMPA Breakthrough Therapy nod in ESCC Innovent’s IBI363 secures third Breakthrough Therapy Designation in China, advancing to Phase III for MSS/pMMR colorectal cancer with Takeda partnership FDA grants Fast Track to Zai Lab’s DLL3‑targeting ADC Zocilurtatug Pelitecan (Zoci) for epNECs (Ref) Zai Lab's : Zocilurtatug pelitecan (Zoci,