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)

April 1st Week, 2025 Regulatory Events 🎯 AstraZeneca's neoadjuvant durvalumab (anti-PD-L1) + chemo followed by adjuvant durvalumab mono has been approved for adults with resectable NSCLC at a high risk of recurrence and no EGFR mutations or ALK rearrangements in the EU. (Ref 1) ❓ What are the other approved regimens in the early-stage NSCLC, and how do the outcomes of the AEGEAN regimen compare against those regimens? 🎯 The US FDA approved AstraZeneca’s neoadjuvant durval

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)