30/06/2026 BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL US FDA approves Orca Bio’s TREGZI™, as first precision‑engineered cell therapy for matched‑donor stem cell transplant in adult hematological malignancies BRUKINSA + rituximab achieves 43% PFS risk reduction in frontline MCL (Ref) BeOne Medicines announced that BRUKINSA (zanubrutinib; BTK inhibitor) combined with rituximab met the primary progression-free survival endpoint in the Phase 3 MANGROVE

June 2nd Week, 2025 Regulatory Events 🎯 The US FDA approved Merck & Co./MSD's pembrolizumab (anti-PD-1) mono Q3W, 2Cy, as a neoadjuvant Tx followed by adjuvant pembro Q3W, 3Cy + RT ± cisplatin after surgery, then pembro mono Q3W, 12Cy, for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. (Ref 1) ❓ What were the factors that influenced the FDA’s decision to limit the label to PD-L1 CPS ≥1? 🎯 The US FDA approved Nuvation Bio’s taletrectinib (ROS1 inhibitor)