Hematology Today—January 5, 2026

This hematology roundup brings together major regulatory decisions, global approvals, and late-stage clinical updates across bispecifics, CAR-T alternatives, engineered grafts, orphan-designated therapies, and supportive care.

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In Today’s Newsletter

🧬 TECVAYLI + DARZALEX FASPRO selected for FDA CNPV pilot [1] [US • 15 Dec 2025]

https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-selected-for-commissioners-national-priority-voucher-pilot-program

Context: sBLA under RTOR; supported by Phase 3 MajesTEC-3 in relapsed or refractory multiple myeloma.

Key point: Statistically significant PFS and OS benefit vs standard regimens after 3 years.

Implication: May influence prescriber choice and payer reviews pending full data.

💊 Minjuvi (tafasitamab) + R + lenalidomide approved by EC for relapsed or refractory FL [2] [EU • 17 Dec 2025]

https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-minjuvir

Context: inMIND Phase 3, n=654.

Key point: Significant PFS improvement; investigator median 22.4 vs 13.9 months.

Implication: May influence prescriber choice and payer reviews pending full data.

💉 FDA approves Lunsumio VELO (SC) for 3L+ FL, ~1-minute dosing [3] [US • 22 Dec 2025]

https://www.roche.com/media/releases/med-cor-2025-12-22

Context: GO29781 Phase I/II in relapsed or refractory FL.

Key point: ORR 75% and CR 59%; manageable CRS.

Implication: May influence prescriber choice and payer reviews pending full data.

🇯🇵 Minjuvi + R + lenalidomide approved in Japan for 2L+ FL [4] [JP • Dec 2025]

https://www.businesswire.com/news/home/20251221198206/en/Incyte-Japan-Announces-Approval-of-Minjuvi-tafasitamab-in-Combination-with-Rituximab-and-Lenalidomide-for-the-Treatment-of-Relapsed-or-Refractory-Follicular-Lymphoma

Context: MHLW approval referencing inMIND.

Key point: First dual CD19/CD20 combo in Japan.

Implication: May affect pricing and formulary access.

🌏 Malaysia approves XPOVIO (selinexor) for DLBCL [5] [MY • 17 Dec 2025]

https://www.prnewswire.com/apac/news-releases/antengene-expands-xpovio-indications-in-malaysia-with-approval-in-diffuse-large-b-cell-lymphoma-302643389.html

Context: sNDA expands XPOVIO uses.

Key point: Approved for adult DLBCL after ≥2 lines.

Implication: Regulatory approval introduces competition.

📘 NCCN adds duvelisib (COPIKTRA) Category 2A for CTCL [6] [US • 17 Dec 2025]

https://www.globenewswire.com/news-release/2025/12/17/3206857/0/en/Secura-Bio-Announces-NCCN-Duvelisib-COPIKTRA-Update-to-Clinical-Practice-Guidelines-in-Oncology-for-Cutaneous-T-Cell-Lymphoma-CTCL-Including-Mycosis-Fungoides-and-S%C3%A9zary-Syndrome.html

Context: NCCN panel consensus.

Key point: Oral PI3K inhibitor recognized.

Implication: Could inform practice and payer discussions.

🧪 AB8939 preprint details dual MoA in refractory AML [7] [15 Dec 2025]

https://www.ab-science.com/wp-content/uploads/2025/12/AB8939-bioRxiv-vENG-VF.pdf

Context: bioRxiv preprint; Phase I/II ongoing.

Key point: Microtubule destabilizer + ALDH inhibitor.

Implication: Early data; interpretation depends on design.

🧫 SELLAS GPS REGAL Phase 3 update [8] [US • 29 Dec 2025]

https://ir.sellaslifesciences.com/news/News-Details/2025/SELLAS-Life-Sciences-Provides-Update-on-Pivotal-Phase-3-REGAL-Trial-of-Galinpepimut-S-GPS-in-Acute-Myeloid-Leukemia-AML/default.aspx

Context: Event-driven OS trial.

Key point: 72 of 80 OS events accrued.

Implication: May influence prescriber choice.

🧵 Roxadustat receives FDA Orphan Drug Designation for MDS [9] [US • 15 Dec 2025]

https://www.globenewswire.com/news-release/2025/12/15/3205285/33525/en/Roxadustat-Granted-Orphan-Drug-Designation-for-the-Treatment-of-Myelodysplastic-Syndromes-by-the-U-S-Food-and-Drug-Administration.html

Context: Cites MATTERHORN signals.

Key point: Phase 3 protocol preparation.

Implication: Signals pipeline investment.

🧫 RoslinCT to manufacture Omisirge for SAA [10] [US • 16 Dec 2025]

https://www.roslinct.com/insights/roslinct-gamidacell-strategic-partnership-to-manufacture-omisirge-for-second-fda-approved-indication/

Context: Expanded partnership.

Key point: Omisirge approved for SAA.

Implication: May expand access and follow-up capacity.

🧩 Masitinib US patent for sickle cell disease [11] [US • 22 Dec 2025]

https://www.ab-science.com/ab-science-patent-for-masitinib-in-the-treatment-of-sickle-cell-disease-formally-granted-in-the-us-with-a-protection-until-2040/

Context: Method-of-use patent.

Key point: Protection through Nov 2040.

Implication: Signals long-term pipeline investment.

🧫 Orca-T Phase 3 improves cGvHD-free survival [12] [US • 15 Dec 2025]

https://orcabio.com/orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies-2/

Context: Precision-T study.

Key point: 1-year cGvHD-free survival 78% vs 38.4%.

Implication: May influence prescriber choice and payer reviews.

🩸 FDA approves FESILTY fibrinogen for CFD [13] [US • 19 Dec 2025]

https://www.grifols.com/en/view-news/-/news/grifols-receives-us-fda-approval-for-new-fibrinogen-concentrate-fesiltytm-fibrinogen-human-chmt

Context: Indicated for acute bleeding in CFD.

Key point: Availability expected H1 2026.

Implication: Introduces competition.

🌍 EMA certifies Grifols Egypt’s plasma value chain [14] [EU • 16 Dec 2025]

https://www.grifols.com/en/view-news/-/news/grifols-obtains-approval-from-the-european-medicines-agency-for-the-entire-value-chain-of-grifols-egypt

Context: EU certification of end-to-end platform.

Key point: Enables domestic supply and possible exports.

Implication: May expand access and screening at scale.

Why it matters

Dual-targeted and bispecific regimens are advancing in FL and MM, potentially shifting earlier-line standards [1][2][3][4].
Subcutaneous, fixed-duration options reduce clinic time and burden [3].
High-precision cell therapies may reduce cGvHD and improve outcomes [12].
Plasma-derived portfolios expand regional resilience [13][14].
Early-stage IP, ODDs, and guidelines reflect investment in SCD, MDS, CTCL, AML [6][7][9][11].

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FAQ

What did MajesTEC-3 show?

Significant PFS and OS improvements in RRMM; supports sBLA CNPV pilot [1].

How strong is the tafasitamab + R + lenalidomide evidence?

Investigator PFS 22.4 vs 13.9 months; supported approvals in EU and Japan [2][4].

What differentiates Lunsumio VELO?

~1-minute SC dosing with 75% ORR and 59% CR [3].

What advantages did Orca-T show?

Improved cGvHD-free survival, lower NRM, fewer infections; Priority Review [12].

What changed for duvelisib?

NCCN Category 2A listing for MF/SS [6].

What are Grifols’ major milestones?

FESILTY approval in CFD and EU certification of Egypt plasma chain [13][14].

Entities / Keywords

Teclistamab (TECVAYLI; J&J), Daratumumab (DARZALEX FASPRO; Janssen) • Tafasitamab (Minjuvi/Monjuvi; Incyte) • Rituximab • Lenalidomide • Mosunetuzumab (Lunsumio VELO; Roche) • Selinexor (XPOVIO; Antengene) • Duvelisib (COPIKTRA; Secura Bio) • AB8939 (AB Science) • Galinpepimut-S, GPS (SELLAS) • Roxadustat (FibroGen) • Omisirge (omidubicel-onlv; Ayrmid/Gamida Cell) • Masitinib (AB Science) • Orca-T (Orca Bio) • FESILTY fibrinogen (Grifols) • Grifols Egypt plasma value chain • FL • DLBCL • MM • AML • CTCL • MDS • SCD • cGvHD • NRM • CRS.