🔬🧬 Oncology Updates: CAR-T Orphan Win, EU NPC Approval, Liver Cancer Combo OK and More
From FDA approvals in liver and colorectal cancers to orphan designations for pancreatic and biliary tract cancers—this week’s oncology roundup showcases groundbreaking innovations driving precision oncology forward.
💡 Key Highlights This Week:
✅ Mustang Bio’s MB-101 CAR-T earns orphan status for glioblastoma and astrocytomas; 50% of patients show stable disease or better
✅ TEVIMBRA approved in EU for nasopharyngeal carcinoma with chemo; 48% PFS risk reduction, OS reaches 45.3 months
🤝 CEL-SCI signs Saudi deal for Multikine with potential 60-day post-approval access and 73% 5-year survival
🫁 Henlius’ HLX43 becomes the first PD-L1 ADC in global Phase 2 for NSCLC; 38.5% ORR in 4L+ patients
🧪 BriaCell’s Bria-IMT outperforms Trodelvy in breast cancer; OS reaches 17.3 months in HR+ MBC
🇰🇷 Korea approves Opdivo + Yervoy combo for advanced liver cancer with 23.7-month OS and 21% death risk reduction
🌐 FDA approves Sirtex’s Y-90 microspheres for unresectable HCC; DOORwaY90 trial shows 98.5% ORR and median DoR over 300 days
🧫 Fujifilm’s FF-10832 earns FDA orphan designation for biliary tract cancer; combines with pembrolizumab in ongoing Phase 2a
🧱 Arcus’ quemliclustat gains orphan status for pancreatic cancer; 15.7-month OS in Phase 1, Phase 3 PRISM-1 enrolling 610 patients
🇨🇳 China approves BRAFTOVI + cetuximab for BRAFV600E-mutant mCRC; 45% risk reduction in NAUTICAL CRC trial
🧬 PDS Biotech advances colorectal program to Stage 2 after RECIST responses in 6 of 9 patients in Stage 1
🧠 Swissmedic approves IFINWIL (eflornithine) for pediatric high-risk neuroblastoma; addresses <50% 5-year survival
🧬 XTANDI + leuprolide shows OS gain in prostate cancer with no new safety signals in EMBARK Phase 3 trial
🎯 Whether you’re tracking next-gen CAR-Ts, tumor microenvironment targets, or global regulatory shifts—this update brings you the latest oncology breakthroughs shaping treatment worldwide.
📢 Stay Ahead in Oncology Research!
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