🔬🧬 Hematology Updates: AML Dose Escalation, Fast Track in CLL, Lymphoma Breakthroughs and More
From AML dosing escalations to landmark lymphoma trial results and breakthrough global approvals—this week’s hematology roundup spotlights the clinical and regulatory milestones shaping the future of blood disorder treatment.
💡 Key Highlights This Week:
✅ Aptose escalates tuspetinib to 160 mg in AML Phase 1/2 TUSCANY trial after strong safety and efficacy; receives $1.1M loan from Hanmi
✅ SELLAS Phase 3 REGAL AML trial continues unchanged after Independent Data Monitoring Committee review; final survival readout expected by year-end
✅ FDA grants Fast Track to Dizal’s birelentinib in CLL/SLL with 84.2% ORR in heavily pretreated patients
🩸 FibroGen to launch Phase 3 roxadustat trial in LR-MDS anemia; MATTERHORN data show 36% transfusion independence vs 7% with placebo
🧬 Genmab’s epcoritamab + R2 in FL hits dual Phase 3 endpoints, achieving 95.7% ORR and 79% progression risk reduction; FDA decision expected Nov 30, 2025
🛑 FDA issues CRL for Regeneron’s odronextamab in FL over site inspection issues; Phase 2 ORR 80.5%, CR 74.2%
🧪 BMS’s Breyanzi accepted for Priority Review in MZL; PDUFA Dec 5, 2025; could be first CAR T in this indication
🧠 Galapagos’ GLPG5101 gains RMAT designation in MCL; ATALANTA-1 shows high ORR and CR with manageable safety
🧷 Allogene selects FC lymphodepletion in ALPHA3 LBCL trial after safety review; futility analysis 1H 2026
🇸🇦 Agios’ PYRUKYND approved in Saudi Arabia for alpha- and beta-thalassemia, transfusion-dependent and independent
🧭 Ouro launches OM336 Phase 1b trial in AIHA and ITP; FDA grants Orphan Drug Designation for AIHA
🎯 Whether you’re tracking next-generation AML agents, lymphoma immunotherapies, or global hematology drug approvals—this episode delivers the must-know developments driving innovation in blood disorder treatment.
📢 Stay Ahead in Hematology Research!
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