15/09/2026 Ivonescimab significantly prolonged OS vs pembrolizumab in 1L PD-L1+ NSCLC in Chinese patients US FDA Fast Track Designation Granted for KST-6051 in Advanced Solid Tumors US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NSCLC US FDA Accepts NDA for Bezuclastinib in Advanced Systemic Mastocytosis CSPC's EGFR ADC SYS6010 Receives NMPA Breakthrough Therapy Designation in NS

28/05/2026 FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST RenovoRx secures FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer Enterome’s EO2463 secures FDA Orphan Drug Designation for indolent NHL FDA grants Priority Review to Cogent’s bezuclastinib + sunitinib combo in GIST (Ref) FDA accepted Cogent’s New Drug Application (NDA) for bezuclastinib + sunitinib in imatinib-pretreated GIST, granting Priority Review with a PDUFA date o

01/04/2026 Cogent completed the NDA submission for bezuclastinib in GIST A2 Bio's A2B543 CAR-T received the FDA fast track designation for certain solid tumors FORE Biotherapeutics' plixorafenib received the FDA breakthrough therapy designation for certain gliomas Cogent completed the NDA submission for bezuclastinib in GIST (Ref) Cogent Biosciences completed the NDA submission to the US FDA for bezuclastinib (KIT inhibitor) in patients with Gastrointestinal Stromal Tumors (G

10/11/2025 Boehringer Ingelheim's zongertinib received the Commissioner’s National Priority Voucher for HER2-mutant NSCLC (Ref) The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. Boehringer Ingelheim is planning a sNDA for zongertinib in the first-line treatment of patients with HER2-mutant NSCLC Previously, zongertinib received accelerated approval by the