🔬🧬 Oncology Updates: IMDELLTRA Breakthroughs, Breast Cancer Advances, and Global Filing Milestones
From landmark survival gains in small cell lung cancer and ESR1-mutant breast cancer to new EMA filings, FDA fast tracks, and China approvals—this week’s oncology roundup captures the latest global advances shaping precision cancer care.
💡 Key Highlights This Week:
✅ Hemispherian’s GLIX1 receives EMA orphan designation for glioma based on strong tumor regression and survival data
✅ IMDELLTRA cuts risk of death by 40 percent in relapsed SCLC; median OS improved to 13.6 months in DeLLphi-304 trial
🧪 Tecentriq + Zepzelca combo improves survival in ES-SCLC (IMforte); median OS extended to 13.2 months with 46 percent PFS risk reduction
📊 PharmaMar files Zepzelca + Tecentriq combo with EMA after ASCO data highlights dual benefit
🧬 Innovent’s IBI363 secures second Breakthrough Therapy Designation in China for PD-1/IL-2 bispecific in immunotherapy-resistant sqNSCLC
📉 Camizestrant reduces progression risk by 56 percent in ESR1-mutant HR+/HER2- breast cancer in the Phase 3 SERENA-6 trial
📤 Arvinas and Pfizer submit NDA for vepdegestrant, an oral PROTAC degrader, in ESR1-mutant breast cancer
🧬 Guardant360 CDx validated as a resistance biomarker in ctDNA-guided treatment switch during SERENA-6
🌍 Amezalpat granted EMA orphan drug status for first-line hepatocellular carcinoma after showing OS gain with atezolizumab + bevacizumab
🇨🇳 China accepts NDA for sintilimab + fruquintinib in advanced RCC following success in FRUSICA-2
🧬 AKEEGA (niraparib + abiraterone) shows 48 percent rPFS benefit in BRCA-mutated mCSPC in AMPLITUDE trial
🎯 Cadonilimab approved in China as first-line treatment for cervical cancer based on COMPASSION-16 survival results
🚀 Pheast’s PHST001 receives FDA fast track designation for platinum-resistant ovarian cancer, targeting CD24 with macrophage activation
🎯 Whether you’re following antibody drug conjugates, ctDNA-guided therapy, or regulatory momentum in global oncology—this update delivers the insights you need to stay informed and ahead.
📢 Stay Ahead in Oncology Research!
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