Hematology Video Recap—December 1, 2025

This biweekly Hematology video recap highlights recent advancements in hematology treatments, including novel drug combinations and guideline inclusions. Key approvals and clinical milestones are shaping new therapeutic options for patients with challenging blood cancers.

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Week 17–23 November 2025
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Transcript

Welcome to the latest edition of Hematology–Oncology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

First, AbbVie reports FDA approval of EPKINLY, epcoritamab-bysp, in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma after at least one prior systemic therapy. In the Phase 3 EPCORE FL-1 study, epcoritamab plus R2 reduced risk of progression or death by 79 percent versus R2 alone, hazard ratio 0.21. Overall response was 89 percent versus 74 percent, with complete response 74 percent versus 43 percent. Median progression-free survival was not reached versus 11.2 months. Cytokine release syndrome occurred in 24 percent, mostly grade 1–2, and one grade 1 ICANS event was reported. This is the first bispecific-antibody combination therapy approval in lymphoma.

Grifols received an FDA label expansion for THROMBATE III, antithrombin III human, to include pediatric patients with hereditary antithrombin deficiency. This makes it the first antithrombin concentrate approved for both adults and pediatrics. Approval was based on data extrapolation from two adult studies. Important safety considerations include hypersensitivity and infection-transmission warnings.

In Japan, Chugai and Nippon Shinyaku updated the electronic package insert for Gazyva, obinutuzumab, enabling use with venetoclax for previously untreated CD20-positive CLL and SLL. The update references Phase II M20-353 in Japan and global Phase III CLL14. Dosing notes direct clinicians to the venetoclax insert and clarify sequencing when combined with acalabrutinib.

Interim 3-year results from the AOZORA post-marketing study in Japan indicate Hemlibra, emicizumab, maintained joint health in most children with hemophilia A without inhibitors. Among 30 boys, treated bleeds declined from 3.6 to 0.8 per year, spontaneous bleeds from 1.3 to 0.2, and treated joint bleeds from 0.5 to 0.2. MRI findings improved or stabilized in most, with some worsening reported. Seven serious adverse events in five boys were not linked to treatment.

Kura Oncology announces KOMZIFTI, ziftomenib, has been added to the NCCN AML Guidelines as a Category 2A option for adults with relapsed or refractory NPM1-mutated AML. FDA approval on 13 Nov 2025 was supported by KOMET-001, with CR or CRh of 21.4 percent and median duration of 5 months. The label carries a boxed warning for differentiation syndrome.

BeOne Medicines reports FDA Priority Review for sonrotoclax, a next-generation BCL2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after a BTK inhibitor. The single-arm Phase 1/2 BGB-11417-201 study in 125 patients met its primary endpoint of overall response by independent review, with additional signals in complete response, duration, and progression-free survival.

Autolus Therapeutics shares that NICE has recommended AUCATZYL, obe-cel, for routine NHS commissioning in England and Wales for adults aged 26 and older with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The decision follows MHRA conditional authorization in April 2025 and FELIX study results.

Finally, Bristol Myers Squibb received European Commission approval to expand Breyanzi, lisocabtagene maraleucel, to adult relapsed or refractory mantle cell lymphoma after at least two lines including a BTK inhibitor. In TRANSCEND MCL, overall response was 82.7 percent with 71.6 percent complete responses, and 41.2 percent of patients remained in response at 24 months. Cytokine release syndrome occurred in 61 percent, grade 3–4 in 1 percent, median onset 4 days. Neurologic events occurred in 31 percent, grade 3–4 in 9 percent, median onset 8 days.

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Why it matters

Bispecifics and oral targeted combinations are moving earlier in lymphomas and CLL, as seen with EPKINLY + R² in FL and Gazyva + venetoclax in frontline CLL/SLL.
Pediatric and rare coagulation indications (THROMBATE III, Hemlibra AOZORA) are tightening preventive strategies to avoid irreversible thrombotic or joint damage.
Guideline and HTA decisions (NCCN for KOMZIFTI, NICE for AUCATZYL, EC for Breyanzi) now drive the practical adoption curve as much as regulatory approvals.
Post-BTKi MCL is rapidly evolving, with both CAR-T (Breyanzi) and targeted small molecules (sonrotoclax) lining up to redefine third-line-plus standards.

🗓️ Explore weekly details and sources

Week 17–23 November 2025
Week 24–30 November 2025

📚 See the full Hematology archive on our research hub page.

FAQ

What line of therapy is EPKINLY + R² approved for in FL?

EPKINLY + R² is approved in the US for adults with relapsed or refractory follicular lymphoma after at least one prior line of systemic therapy, based on EPCORE FL-1.[1]

What changed for THROMBATE III in the US label?

THROMBATE III is now indicated for both adult and pediatric patients with hereditary antithrombin deficiency for treatment and prevention of thromboembolism and perioperative/peripartum risk, making it the only AT concentrate with this breadth of labeled use.[2]

How does the Gazyva + venetoclax update affect CLL treatment in Japan?

The insert now explicitly supports use of Gazyva with venetoclax for previously untreated CD20+ CLL/SLL and defers dosing details to the venetoclax label, operationalizing a CLL14-like regimen in Japanese practice.[3]

What does AOZORA tell us about long-term Hemlibra use in children?

Three-year interim data in 30 boys show sustained bleed reduction, stable or improved joint imaging and function, and no new major safety signals, supporting continuous Hemlibra prophylaxis from early childhood.[4]

What does NCCN Category 2A status mean for KOMZIFTI?

Category 2A indicates uniform NCCN consensus that KOMZIFTI is an appropriate option for R/R NPM1-mutated AML based on available evidence, which strongly supports payer coverage and clinical adoption.[5]

Where will sonrotoclax likely fit in MCL treatment?

If approved, sonrotoclax is poised for use in adults with R/R MCL after BTKi therapy, potentially as an oral targeted alternative or bridge before cellular therapies in appropriate patients.[6]

What did NICE decide about AUCATZYL?

NICE recommended AUCATZYL for routine NHS commissioning in England and Wales for adults ≥26 with R/R B-cell precursor ALL, moving it beyond interim access schemes into standard funded care.[7]

What exactly did the EC approve for Breyanzi in MCL?

The EC approved Breyanzi for adults with R/R mantle cell lymphoma after at least two prior systemic lines, including a BTK inhibitor, with applicability across all EU and EEA countries (excluding the UK).[8]

Entities / Keywords

Soligenix; HyBryte, SGX301; CTCL; FLASH2. BioInvent; BI-1808; TNFR2; Orphan Drug Designation; EMA. Roche; Lunsumio, mosunetuzumab; subcutaneous; follicular lymphoma. AbbVie; EPKINLY, epcoritamab; rituximab; lenalidomide; EPCORE FL-1. Chugai; Nippon Shinyaku; Gazyva, obinutuzumab; Venclexta, venetoclax; CLL14. Medunik USA; Duchesnay; Siklos, hydroxyurea; SCD. Agios; mitapivat; RISE UP; SCPC; PROMIS Fatigue. Grifols; THROMBATE III; hereditary antithrombin deficiency. CSL; plasma-derived therapies. Hemlibra, emicizumab; AOZORA; pediatric HemA.