🔬🧬 Oncology Updates: Iza-bren FDA Breakthrough, Inhaled KB707 Data, AI in Bladder Cancer and More
From the FDA’s latest designations for lung and gastric cancers to Canada’s approval of TIL and prostate therapies—and an AI copilot reshaping bladder cancer research—this week’s oncology roundup showcases innovations driving precision oncology and global regulatory momentum.
đź’ˇ Key Highlights This Week:
âś… Iza-bren earns FDA Breakthrough Therapy Designation for EGFR-mutant NSCLC following EGFR TKI and platinum chemotherapy; supported by 3 clinical trials
âś… Inhaled KB707 from Krystal Biotech shows 36% ORR in pre-treated NSCLC; designed to express IL-2 and IL-12 for immune modulation
🧬 I-DXd, a B7-H3-directed ADC from Daiichi Sankyo and Merck, gets FDA BTD for small cell lung cancer; full Phase 2 data expected at WCLC 2025
🇨🇦 Lifileucel (Amtagvi) approved by Health Canada for advanced melanoma; marks first TIL therapy for solid tumors outside the U.S.
🧫 Cadonilimab begins global Phase 3 COMPASSION-33 trial for resectable gastric and GEJ adenocarcinoma in perioperative setting
🔬 ATG-022 receives Breakthrough Therapy Designation in China for CLDN18.2-positive gastric/GEJ cancer after ≥2 prior therapies
⚡ Novocure files PMA for TTFields in unresectable pancreatic cancer; median OS nearly doubled vs. chemotherapy alone
🧬 NICE endorses enfortumab vedotin + pembrolizumab as first-line therapy for advanced bladder cancer with 33.8-month median OS
👨‍⚕️ Nubeqa approved in Canada for metastatic castration-sensitive prostate cancer; 46% risk reduction in ARANOTE Phase 3
🤖 Owkin and MedUni Vienna launch AI copilot “Owkin K” to accelerate bladder cancer research via multimodal data and patient stratification
🎯 Whether you’re following immunotherapy advances, antibody-drug conjugates, or AI in oncology—this episode captures the leading-edge developments reshaping global cancer care.
📢 Stay Ahead in Oncology Research!
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