This hematology video covers major regulatory and guideline milestones across hematologic malignancies, with multiple approvals, filings, and access expansions. Highlights span lymphoma, multiple myeloma, myelodysplastic syndromes, and rare hematologic disorders, reflecting rapid therapeutic progress and global reach.
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Top Stories Covered in This Video
Chapter
0:00 Introduction
0:08 EC clears tafasitamab + lenalidomide + rituximab for r/r FL
0:48 FDA grants accelerated approval to subcutaneous mosunetuzumab for 3L+ FL, about 1 minute injection
1:28 NCCN adds duvelisib as Category 2A option for MF/SS in CTCL
1:56 FDA grants Orphan Drug Designation to roxadustat for MDS
2:21 EMA filing submitted for teclistamab + daratumumab SC in RRMM after ≥1 prior therapy
2:59 Managed access for revumenib expands outside the US via Syndax–WODA
3:33 China approves sonrotoclax for R/R MCL and CLL/SLL, first in world for next-generation BCL2 inhibitor
4:13 US NDA submitted for rusfertide in PV, targeting hematocrit control and reduced phlebotomy burden
4:38 How to reach us
Transcript
Welcome to the latest edition of Hematology Updates, covering recent breakthroughs in the field. Brought to you by LucidQuest.
The European Commission approved Minjuvi, tafasitamab, with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma after at least one prior therapy. This chemo-free, CD19 and CD20 dual-targeted triplet is supported by the Phase 3 inMIND study in 654 patients showing a progression-free survival benefit versus placebo plus lenalidomide and rituximab, with safety consistent with the components. Expect new competition that could shape pricing and formulary access.
The FDA granted accelerated approval to subcutaneous Lunsumio VELO, mosunetuzumab, for third line or later follicular lymphoma. In the Phase 1 Phase 2 GO29781 primary analysis, overall response rate was 75 percent and complete response was 59 percent, with cytokine release syndrome mostly Grade 1 to 2. Administration is about 1 minute by injection, compared with 2 to 4 hours for intravenous infusion, which may influence prescriber choice and payer reviews as more data mature.
The NCCN added duvelisib, COPIKTRA, as a Category 2A option for mycosis fungoides and Sézary syndrome in cutaneous T-cell lymphoma, reflecting panel consensus above 85 percent. Duvelisib is already FDA-approved for relapsed or refractory CLL or SLL, and this guideline inclusion can inform practice and payer discussions as adoption progresses.
The FDA granted Orphan Drug Designation to roxadustat for myelodysplastic syndromes. A post-hoc MATTERHORN analysis suggested a transfusion-independence benefit in a subset with high transfusion burden. The designation aligns with plans to finalize a Phase 3 protocol, signaling continued investment in this program.
Johnson and Johnson submitted an EMA application for teclistamab combined with subcutaneous daratumumab in relapsed or refractory multiple myeloma after at least one prior therapy. Phase 3 MajesTEC-3, in 587 patients, showed significant improvements in progression-free and overall survival versus DPd or DVd, with infections noted for clinical management. This off-the-shelf BCMA and CD38 combination aims for earlier-line use and could guide treatment selection pending review.
Syndax and the World Orphan Drug Alliance launched a multi-regional managed access program for Revuforj, revumenib, outside the United States where regulations permit. Geographies include parts of Eurasia, Europe, Israel, the Middle East, Turkey, Latin America, and Africa. The program could broaden access to this FDA-approved menin inhibitor for specific relapsed or refractory acute leukemias and support screening, initiation, and follow-up at scale.
China approved sonrotoclax for relapsed or refractory mantle cell lymphoma and for relapsed or refractory CLL or SLL. Phase 1 Phase 2 data presented at ASH showed an overall response rate of 52.4 percent in mantle cell lymphoma, n equals 103, and 77 percent in CLL or SLL, n equals 100. This first-in-world approval for a next-generation BCL2 inhibitor, alongside ongoing U.S. priority review for MCL, may reshape pricing and formulary dynamics.
Takeda and Protagonist submitted a U.S. New Drug Application for rusfertide in polycythemia vera. Phase 3 VERIFY met the primary and all four key secondary endpoints, with weekly subcutaneous dosing. The application seeks approval for hematocrit control and reduction of phlebotomy burden, which could meaningfully affect patient management if approved.
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FAQ
What did the EC approve for follicular lymphoma?
Minjuvi (tafasitamab) with lenalidomide and rituximab for adult r/r FL after at least one prior therapy, supported by Phase 3 inMIND PFS benefit [1].
How does Lunsumio VELO differ from IV Lunsumio?
VELO is a subcutaneous formulation of mosunetuzumab for 3L+ FL with ~1-minute administration, granted accelerated approval based on GO29781 response data [2].
Is duvelisib now a standard for CTCL?
NCCN added duvelisib as Category 2A for MF/Sézary syndrome, indicating uniform consensus support; this is a guideline recommendation, not an FDA label change for CTCL [3].
What is the basis for roxadustat’s ODD in MDS?
FDA granted Orphan Drug Designation, with the company citing post-hoc MATTERHORN findings in a high transfusion-burden subset and plans for Phase 3 protocol submission [4].
What evidence backs J&J’s EMA filing in RRMM?
Phase 3 MajesTEC-3 showed significant PFS and OS improvements for teclistamab + daratumumab SC vs DPd/DVd; safety included infections and cytopenias [5].
Where will Revuforj managed access be available?
Select parts of Eurasia, Central and Southeast Europe, Israel, Middle East and Turkey, Latin America, and Africa, per local regulations and funding pathways [6].
🗓️ Explore weekly details and sources
📚 See the full Hematology archive on our research hub page.
Entities / Keywords
Follicular lymphoma; Minjuvi, tafasitamab (Incyte); lenalidomide; rituximab; mosunetuzumab, Lunsumio VELO (Roche); duvelisib, COPIKTRA (Secura Bio); CTCL, MF/SS; roxadustat (FibroGen); MDS; teclistamab, TECVAYLI; daratumumab, DARZALEX (Johnson & Johnson); multiple myeloma; revumenib, Revuforj (Syndax); managed access; sonrotoclax (BeOne Medicines); BCL2 inhibitor; MCL; CLL/SLL; rusfertide (Takeda, Protagonist); polycythemia vera.
References
https://www.roche.com/media/releases/med-cor-2025-12-22
https://www.takeda.com/newsroom/newsreleases/2025/new-drug-application-pv/