17/08/2026 Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC AstraZeneca halts Phase 3 eVOLVE-Lung02 trial of volrustomig in mNSCLC ORPATHYS + TAGRISSO deliver survival benefit in MET-driven EGFRm NSCLC US FDA fast track designation granted for PIKTOR + paclitaxel in biomarker-selected advanced Endometrial Cancer UroGen submits NDA for UGN-103 in recurrent LG-IR-NMIBC Enhertu delivers first-ever PFS benefit in 1L HER2-mutant NSCLC (Ref) AstraZeneca and Daiichi S

30/07/2026 NMPA grants priority review to sacituzumab tirumotecan for first‑line TNBC FDA Advisory Committee Backs RP1's Efficacy Data in Advanced Melanoma FDA Grants Orphan Drug Designation to Enzomenib for Acute Lymphoblastic Leukemia REVTORPYK (gedatolisib) Added to NCCN Guidelines for HR+/HER2- Breast Cancer Karyopharm to file sNDA in Aug 2026, for selinexor + ruxolitinib in Myelofibrosis under accelerated approval pathway Selinexor Phase 3 Endometrial cancer trial shows

15/07/2026 Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC KEYTRUDA delivers first-ever PFS benefit over chemotherapy in frontline dMMR endometrial cancer Sacituzumab tirumotecan (sac-TMT) + pembrolizumab improved PFS vs chemo + pembrolizumab in PD-L1–negative NSCLC (Ref) Sichuan Kelun-Biotech announced positive Phase 3 OptiTROP-Lung06 trial results for its TROP2 ADC sacituzumab tirumotecan (sac-TMT, SKB264/MK-28

May 3rd Week, 2026 Regulatory Events 🎯 Shanghai Junshi Biosciences Co Ltd’s NDA for toripalimab (anti-PD-1) + RemeGen Biosciences’ disitamab vedotin (HER2 ADC) for patients with HER2-expressing LA/M urothelial carcinoma was approved by the NMPA. (Ref 1) ❓ What are the clinical outcomes that support this approval? Special Designations ⭐ The US FDA granted the Priority Review status to Bayer’s sevabertinib (HER2 TKI) for the first-line treatment of adult patients with LA/M

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

12/05/2026 FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid

26/08/2025 Genmab's Rina-S ADC received the Breakthrough Therapy Designation from the FDA for endometrial cancer (Ref) The US FDA granted the Breakthrough Therapy Designation to Genmab's rinatabart sesutecan (FRα-directed, TOPO1-inhibitor ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy. The designation was based on re