29/10/2025 Merck's perioperative Keytruda regimen received approval from the EC for LA SCCHN with PD-L1 CPS ≥1 (Ref) The European Commission (EC) has approved Merck & Co./MSD's pembrolizumab (anti-PD-1) single agent as a neoadjuvant Tx followed by adjuvant pembrolizumab + RT with or without cisplatin after surgery, and then as a single agent for adults with resectable locally advanced SCCHN with PD-L1 CPS ≥1. The approval follows a positive CHMP opinion, and is based on resul

May 4th Week, 2025 Regulatory Events 🎯 The US FDA granted a Fast Track designation to CSPC Pharmaceutical Group ’s CPO301 (SYS6010; EGFR ADC) for the Tx of oncogenic driver mutation negative, non-squamous NSCLC patients who have progressed on prior platinum chemotherapy and anti-PD-(L)1 therapy. (Ref 1) ❓ Which other ADCs are being developed for this setting? 🎯 Zai Lab's ZL-1310 (DLL3 ADC) was granted a Fast Track designation by the US FDA for the Tx of ES-SCLC patients