12/06/2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC AbbVie's Venetoclax Shows Sustained 9-Year Efficacy in First-Line CLL at EHA 2026 Jazz Pharmaceuticals' Zepzelca Phase 3 LAGOON Trial Misses Primary Endpoint in Second-Line SCLC (Ref) The Phase 3 LAGOON trial, evaluating Zepzelca (lurbinectedin) in relapsed/second-line metastatic small cell lung cancer (SCLC), did not meet its primary endpoint of overall survival (OS) fo

October 1st Week, 2025 Regulatory Events 🎯 The US FDA approved Jazz Pharmaceuticals' lurbinectedin (DNA alkylating agent) + Roche's atezolizumab (anti-PD-L1) as a maintenance Tx for adults with ES-SCLC whose disease has not progressed after first-line induction Tx with atezolizumab, carboplatin and etoposide. (Ref 1) ❓ How is this approval expected to impact the Tx paradigm? 🎯 AstraZeneca and Daiichi Sankyo’s sBLA for trastuzumab deruxtecan (HER2 ADC) followed by paclitaxel

02/10/2025 Aminex Therapeutics' AMXT 1501 + DFMO received the FDA Orphan Drug Designation for Neuroblastoma (Ref) The US FDA granted the Orphan Drug Designation to Aminex Therapeutics' AMXT 1501 (polyamine transport inhibitor) + difluoromethylornithine for the treatment of patients with neuroblastoma. Mark Burns, CSO and President, Aminex Therapeutics: "Receiving Orphan Drug Designation for AMXT 1501 in combination with DFMO represents an important milestone in our mission to

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)