18/05/2026 Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy FDA grants Priority Review to Bayer’s HYRNUO® (sevabertinib) for first-line treatment of HER2-mutated NSCLC Sacituzumab tirumotecan (Sac‑TMT) delivers survival benefit in advanced endometrial cancer, meeting OS and PFS endpoints over chemotherapy (Ref) The Phase 3 TroFuse-005 study of sacituzumab tirumotecan (Sac‑TMT), a TROP2-d

24/02/2026 Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC Siren Biotechnology's SRN-101 received the FDA fast track designation for HGG Aktis Oncology's AKY-1189 received the FDA fast track designation for mUC Onconic Therapeutics' nesuparib received the FDA orphan drug designation for SCLC Pfizer's encorafenib + cetuximab + chemo received FDA traditional approval for CRC ( Ref ) The US FDA granted traditional approval to Pfizer's encorafen

28/07/2025 sNDA for Akeso and Summit's ivonescimab (PD-1 x VEGF bispecific antibody) + chemotherapy for sqNSCLC accepted by China's NMPA...

14/07/2025 Henlius’ Ph3 trial of HLX22 combo has dosed the first HER2+ GC patient in the US ( Ref ) Shanghai Henlius Biotech announced...

10/07/2025 TEVIMBRA + chemotherapy has been approved in EU as a first-line treatment for NPC ( Ref ) The EC approved BeOne Medicines'...