🔬🧬 Oncology Updates: Glioma Drug Win, HER2+ Cancer Trials, First-in-Class ADC and More
From FDA orphan drug designations to pivotal trial launches in China and first-in-class bispecific ADCs—this week’s oncology roundup delivers vital updates reshaping cancer research and treatment across solid tumors and hematologic malignancies.
💡 Key Highlights This Week:
✅ Hemispherian’s GLIX1 receives FDA Orphan Drug designation for glioma with preclinical tumor regression and survival benefit
✅ HUTCHMED’s ORPATHYS + TAGRISSO combo approved in China for MET-amplified NSCLC; 66% reduced progression risk vs chemo
🧪 ExpreS2ion expands Austrian Phase 1 breast cancer immunotherapy trial for ES2B-C001 + HER2-targeted ADCs
🍽️ Zai Lab’s bemarituzumab meets OS endpoint in FGFR2b+ gastric cancer; regulatory submission planned in China
🌐 Jazz Pharma’s Ziihera (zanidatamab) approved in EU for HER2+ biliary tract cancer with 41.3% response rate
🇨🇳 Tempest clears pivotal Phase 3 trial in China for amezalpat + atezolizumab + bevacizumab in liver cancer
🇪🇺 Imfinzi becomes first perioperative immunotherapy approved in the EU for bladder cancer; 32% recurrence and 25% death risk reduction
🧬 AB Science receives FDA/EMA go-ahead for Phase 3 trial of masitinib in prostate cancer with 0.79 hazard ratio for PFS
🇪🇺 J&J submits EMA application to expand AKEEGA use in HRR-mutated hormone-sensitive prostate cancer
🔬 Akeso begins global trial of AK146D1, first Trop2/Nectin4 bispecific ADC in solid tumors across China, US, and Australia
🎯 Whether you’re following HER2-targeted therapies, breakthrough trial initiations, or novel ADC platforms—this episode covers the global momentum in oncology drug development.
📢 Stay Ahead in Oncology Research!
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