September 3rd Week, 2026 Regulatory Events 🎯 AstraZeneca’s sBLA for perioperative durvalumab (Imfinzi; anti-PD-L1) + Astellas Pharma and Pfizer’s neoadjuvant enfortumab vedotin (Padcev; Nectin-4 ADC) was accepted and granted Priority Review by the US FDA for the Tx of MIBC patients who are ineligible/have declined cisplatin-based chemotherapy (Ref1) ❓ What are the current efficacy benchmarks for perioperative MIBC? 🎯 The US FDA approved Merck&Co/MSD's belzutifan (Welir

24/09/2026 US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant OS benefit CSPC reports positive Phase III results for becotatug + osimertinib, demonstrating significant PFS benefit and favorable OS trend in first-Line EGFR Exon20ins NSCLC US FDA approves belzutifan + lenvatinib in post-IO advanced ccRCC based on PFS superiority over cabozantinib, despite no statistically significant

11/09/2026 Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules Immutep refocuses eftilagimod alfa development on PD-L1-negative (CPS <1) HNSCC and neoadjuvant STS following TACTI-004 discontinuation SERENA-4 Phase 3 trial of Etcamah + palbociclib missed its primary PFS endpoint in 1L ER+/ HER2- advanced breast cancer Handa Secures final US FDA approval for OMCAZIO™ Cabozantinib capsules (Ref) Handa Pharmaceuticals has received final US FDA approval for OMCA

31/07/2026 FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption Annamycin shows 37% CRc in Venetoclax-failed AML patients, with unblinded arms reaching up to 57% FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption (Ref) Handa Oncology announced that the US FDA has granted tentative approval for OMCAZIO (cabozantinib; multikinase inhibitor) capsules, a novel alternate-sal

21/04/2026 Phase 3 LITESPARK-012: Triplet and Doublet Regimens Fail to Surpass KEYTRUDA + LENVIMA in Advanced RCC Phase 3 LITESPARK-012: Triplet and Doublet Regimens Fail to Surpass KEYTRUDA + LENVIMA in Advanced RCC (Ref) Merck & Co. and Eisai announced that their Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for first-line treatment of advanced clear cell RCC. Both experimental combination re

17/11/2025 Dewpoint Therapeutics' DPTX3186 received the FDA fast track designation for gastric cancer (Ref) The US FDA granted the fast track designation to Dewpoint Therapeutics' DPTX3186 (oral condensate modulator) for the treatment of gastric cancer. Isaac Klein, CSO and Head of R&D, Dewpoint Therapeutics: “We are honored that the FDA has recognized the urgency of gastric cancer and the promise of our condensate-based approach. DPTX3186 represents a new way of modulating d

28/10/2025 Alphamab Oncology's JSKN003 received the FDA fast track designation for PROC (Ref) The US FDA granted the fast track designation to Alphamab Oncology's JSKN003 (biparatopic HER2-targeting antibody-drug conjugate) for the treatment of advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC). To note, in Sep'24, Alphamab entered a licensing agreement with JMT-Bio Technology (a wholly-ow