🔬🧬 Hematology Updates: CAR-T Hits 75% ORR, Blenrep FDA Hurdle, Columvi Rejected and More
From CAR-T success in DLBCL to orphan drug designations and delayed FDA approvals—this week’s hematology roundup spotlights major regulatory, clinical, and commercial milestones redefining blood disorder therapeutics.
đź’ˇ Key Highlights This Week:
Â
✅ GSK’s Blenrep meets FDA panel resistance over benefit-risk profile; PDUFA decision due July 23
✅ Imugene’s CAR-T azer-cel achieves 75% ORR in r/r DLBCL; first patient remains cancer-free at 15+ months
📩 FDA rejects Roche’s Columvi combo for 2L DLBCL; 3L+ use retained pending SKYGLO trial results
đź’‰ Aptose secures $2M from Hanmi to advance TUS+VEN+AZA triplet for AML; early CRs seen in TP53-mutated and wild-type disease
🧬 ImCheck’s ICT01 earns FDA Orphan Drug Designation in AML; BTN3A-targeting γ9δ2 T cell activator shows high remission rates
🧪 Bristol Myers’ Reblozyl trial misses myelofibrosis primary endpoint; secondary metrics show improved Hb and reduced transfusion burden
🏠Grifols invests €160M to double plasma processing in Europe; new plant in Spain to serve over 300,000 patients by 2030
🔬 GC Biopharma reports lower IVIG viscosity with ALYGLO at room temp; G-XI™ tech may reduce thromboembolic risk
🧠Complement activation identified as key driver in sickle cell acute chest syndrome; complement inhibitors reverse RBC destruction in models
đź’Š B. Braun launches new 25,000 Unit premixed Heparin bags in 0.45% sodium chloride; expands U.S. portfolio
đź’° Genmab announces $3.5B in Q2 DARZALEX sales; $2B from U.S., $1.5B from global markets via Janssen royalties
🛑 FDA delays Atara’s Ebvallo due to third-party manufacturing issues; no safety or efficacy concerns, EU approval already granted
🎯 Whether you’re following CAR-T advancements, AML triplet regimens, or sickle cell immunology—this episode delivers essential insights shaping the hematology landscape.
📢 Stay Ahead in Hematology Research!
âś… Like, share, and subscribe for weekly updates on hematology breakthroughs and blood disorder innovation
#Hematology #CAR_T #BloodCancer #AML #DLBCL #SickleCell #IVIG #Reblozyl #DARZALEX #FDAUpdate #OrphanDrug #Heparin #LucidQuest #ClinicalTrials #BiotechNews #PharmaInnovation #PlasmaTherapies #OncologyResearch #BTN3A #GSK #Imugene #ImCheck #Atara #BMS #Roche #Genmab #Grifols #GCbiopharma #HealthcareUpdates