🔬🧬 Hematology Updates: Sarclisa EU Approval, Tab-cel Priority Review, Blenrep Combo Win and More
From Sanofi’s EU nod for newly diagnosed multiple myeloma to the first carbon monoxide-based sickle cell trial and Tab-cel’s Priority Review for EBV+ PTLD—this week’s hematology roundup spotlights global breakthroughs transforming blood cancer treatment and rare blood disorder care.
💡 Key Highlights This Week:
 ✅ Sanofi’s Sarclisa approved in the EU for transplant-eligible newly diagnosed multiple myeloma based on GMMG-HD7 trial results showing superior MRD negativity and PFS
✅ GSK’s Blenrep combinations BVd and BPd gain EU approval for relapsed/refractory myeloma after ≥1 prior therapy, with strong OS and PFS data from DREAMM-7 and DREAMM-8
🧪 ImCheck’s ICT01 receives EMA Orphan Drug Designation for AML, targeting gamma delta T cells with potential for chemo-ineligible patients
🧫 Autolus’ AUCATZYL (obe-cel) CAR-T therapy granted EU marketing authorization for relapsed/refractory B-ALL, showing 76.6% CR/CRi in FELIX trial
🧠Imbruvica (ibrutinib) approved by European Commission as the first BTK inhibitor for previously untreated mantle cell lymphoma based on TRIANGLE trial
💉 Roche’s Polivy reimbursed in Québec for 1L large B-cell lymphoma, reducing progression/relapse risk by 27% when combined with R-CHP
🇺🇸 Atara’s Tab-cel receives FDA Priority Review for EBV+ PTLD with 48.8% ORR in pivotal ALLELE study; PDUFA date set for January 10, 2026
🩸 Novo Nordisk’s Alhemo (concizumab) gains CHMP backing for haemophilia A and B without inhibitors; Explorer8 trial shows up to 86% bleed reduction
🔬 Hillhurst begins Phase 2a trial of oral low-dose carbon monoxide therapy HBI-002 for vaso-occlusive crises in sickle cell disease
👶 Sobi’s Doptelet approved by FDA for pediatric ITP ages 1+, with 27.8% durable response in AVA-PED-301 trial and new sprinkle formulation for toddlers
🎯 Whether you’re following CAR-T approvals, BTK breakthroughs, or novel approaches in rare hematologic diseases—this episode delivers the insights defining hematology innovation today.
📢 Stay Ahead in Hematology Research!
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