July 4th Week, 2025 Regulatory Events 🎯 The EC approved Bayer and Orion Pharma’s darolutamide (androgen receptor inhibitor) + androgen deprivation therapy for the Tx of metastatic hormone-sensitive prostate cancer. (Ref 1) ❓ How is this approval going to impact the Tx paradigm of mHSPC? 🎯 The EC approved Roche's inavolisib (PIK3CA inhibitor) + palbociclib + fulvestrant for the Tx of PIK3CA-mutated, ER+ve, HER2-ve, LA/M breast cancer, following recurrence on or within 12

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC (Ref) The US FDA approved AstraZeneca and Daiichi's datopotamab deruxtecan (Datroway; TROP2 ADC) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. The indication is approved under accelerated approval based on ORR and DoR results from a subgroup analysis of

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)

May 5th Week, 2025 Regulatory Events 🎯 The EC approved Bristol Myers Squibb’s subcutaneous nivolumab (Opdivo Quantig; anti-PD-1) co-formulated with Halozyme, Inc.’s recombinant human hyaluronidase (rHuPH20) for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab + ipilimumab IV, or in combination with chemotherapy or cabozantinib. (Ref 1) ❓ What is the development status of other key subcutaneous immune checkpoint