April 4th Week, 2026 Regulatory Events 🎯 The EC granted conditional marketing authorization to Ipsen’s tovorafenib (Ojemda; type II RAF kinase inhibitor) monotherapy for the treatment of pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (Ref 1) ❓ What is the addressable market for pLGG in EU? 🎯 The US FDA accepted a supplemental BLA for Pfizer and Astellas Pharma’s

21/04/2026 Phase 3 LITESPARK-012: Triplet and Doublet Regimens Fail to Surpass KEYTRUDA + LENVIMA in Advanced RCC Phase 3 LITESPARK-012: Triplet and Doublet Regimens Fail to Surpass KEYTRUDA + LENVIMA in Advanced RCC ( Ref ) Merck & Co. and Eisai announced that their Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for first-line treatment of advanced clear cell RCC. Both experimental combination

October 5th Week, 2025 Regulatory Events 🎯 The EC approved Merck & Co./ MSD 's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT ± cisplatin after surgery, and then as a single agent for adults with resectable LA SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ How is this approval expected to impact the treatment algorithm of LA SCCHN? Clinical Events 🔬 Merck & Co./ MSD and Eisai US reported that the Phase 3 LITESPARK-011 trial of b

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC ( Ref ) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-