Hematology Today—February 9, 2026

LucidQuest

2 months ago

This weekly Hematology update covers regulatory actions, clinical trial progress, data presentations, market entries, and designations across hematologic malignancies and rare bleeding disorders. Themes include label changes, priority reviews, chemo-free cell therapy studies, transplant innovations, and early ADC and in vivo CAR programs.

In Today’s Newsletter

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⚡ Rapid same-day mobilization with burixafor in MM/NHL [1] [US • 05 Feb 2026]

https://investors.exicuretx.com/news/news-details/2026/Exicure-Announces-Publication-in-Annals-of-Hematology-Highlighting-Rapid-Stem-Cell-Mobilization-with-Burixafor-in-Patients-with-Multiple-Myeloma-and-Lymphoma-Undergoing-Transplant/default.aspx
Context: 12-patient, multi-center, open-label Phase 2 (NCT02104427) of burixafor + G-CSF in ASCT candidates.
Key point: 92% met ≥5.0 × 10⁶ CD34+ cells/kg within ≤2 apheresis; peak mobilization ~1 hour enabled same-day collection; safety generally well tolerated.
Implication: May expand screening, initiation, and follow-up at scale.

💊 Lupin launches dasatinib tablets in the US [2] [US • 02 Feb 2026]

https://www.lupin.com/lupin-launches-dasatinib-tablets-in-the-united-states/
Context: ANDA approval for 20–140 mg, bioequivalent to Sprycel; developed with Pharmascience.
Key point: Indicated per RLD across Ph+ CML and Ph+ ALL in adults and pediatrics.
Implication: Introduces competition that may affect pricing and formulary access.

🧠 Yescarta label update removes PCNSL limitation of use [3] [US • 2026]

https://www.gilead.com/news/news-details/2026/fda-approves-label-update-for-kites-yescarta-for-relapsedrefractory-primary-central-nervous-system-lymphoma
Context: FDA action based on Phase 1 investigator-sponsored study in R/R PCNSL.
Key point: Limitation of use removed for PCNSL, with no new safety signals in the update.
Implication: May influence prescriber choice and payer reviews pending full data.

🎙️ Breyanzi awareness with Kasey Keller for World Cancer Day [4] [US • 04 Feb 2026]

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Teams-Up-with-Kasey-Keller-to-Share-His-Lymphoma-Journey-with-Breyanzi/default.aspx
Context: Patient story campaign highlighting lisocabtagene maraleucel in NHL.
Key point: Addresses low utilization of CAR-T among eligible patients, focusing on education and access.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🧪 DS3790, first DXd ADC in hematology for Daiichi Sankyo, enters clinic [5] [04 Feb 2026]

https://daiichisankyo.us/press-releases/-/article/ds3790-enters-clinical-development-as-first-dxd-adc-in-hematology-from-industry-leading-adc-portfolio-of-daiichi-sankyo
Context: First-in-human Phase 1/2 in relapsed or refractory B-cell NHL, global multi-cohort design.
Key point: CD37-directed DXd ADC, monotherapy escalation then expansion and planned combinations; target enrollment ~420.
Implication: Signals pipeline investment and modality expansion.

🧬 Chemo-free, lymphodepletion-free CAR-NK + ANKTIVA in iNHL [6] [US • 02 Feb 2026]

https://ir.immunitybio.com/news-releases/news-release-details/immunitybio-launches-phase-2-chemotherapy-free-car-nk-cell
Context: Phase 2 ResQ215B uses off-the-shelf CD19 t-haNK + ANKTIVA + rituximab in iNHL, including Waldenström’s.
Key point: Builds on Phase 1 experience of outpatient CAR-NK + rituximab without chemo showing durable responses in small cohorts.
Implication: May influence prescriber choice and payer reviews pending full data.

🚚 Orca-T durability and logistics reinforced at Tandem 2026 [7] [US • 05 Feb 2026]

https://orcabio.com/orca-bio-presents-new-data-at-the-2026-tandem-meetings-of-astct-and-cibmtr-reinforcing-orca-t-as-a-durable-high-precision-cell-therapy-for-hematological-malignancies/
Context: Retrospective comparisons vs PTCy regimens; first patients dosed in Phase 2 SERENE-T (RIC/NMA).
Key point: Analyses suggest improved OS/RFS/GRFS and low severe GVHD; 100% product delivery within 70 hours in manufacturing report.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 In vivo CAR-T shows complete B-cell depletion and redosing in NHPs [8] [02 Feb 2026]

https://createmedicines.com/news/create-medicines-demonstrates-complete-b-cell-depletion-and-repeatable-dosing-in-non-human
Context: Keystone data from RNA-LNP in vivo CAR platform in non-human primates.
Key point: Complete B-cell depletion with next-gen receptor designs and repeat dosing; clinical entry planned H2 2026.
Implication: Signals pipeline investment and modality expansion.

🧩 Desidustat receives USFDA Orphan Drug Designation for SCD [9] [US • 06 Feb 2026]

https://zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-USFDA-Orphan-Drug-Designation-(ODD)-for-Desidustat-for-the-treatment-of-Sickle-Cell-Disease.pdf
Context: Oral HIF-PHI aimed at boosting hemoglobin and RBC counts; Phase 2 in SCD completed (details not provided).
Key point: ODD grants eligibility for tax credits, fee waivers, and potential 7-year exclusivity upon approval.
Implication: Introduces competition that may affect pricing and formulary access.

🩸 HYMPAVZI (marstacimab) sBLA gets FDA Priority Review [10] [US • 06 Feb 2026]

https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-hympavzir-marstacimab-sbla
Context: Expansion sought for patients ≥6 with inhibitors, and children 6–11 without inhibitors; Breakthrough Therapy Designation for a subset.
Key point: If approved, first non-factor prophylaxis for children 6–11 with hemophilia B; PDUFA in Q2 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Faster mobilization and outpatient cell-therapy regimens could reduce center load and patient burden.
New modalities and targets, including CD37 ADCs and in vivo CARs, broaden hematology options.
Label and pediatric access changes can shift referral patterns quickly.
Proven manufacturing and distribution performance is a key differentiator for cell therapy scale.

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FAQ

How fast is burixafor mobilization compared with other CXCR4 inhibitors?

Peak CD34+ mobilization occurred within ~1 hour, enabling same-day apheresis in a small Phase 2 with G-CSF, with generally well tolerated safety [1].

Does Yescarta now include primary CNS lymphoma patients?

The FDA removed the prior limitation of use for R/R PCNSL, supported by an investigator-sponsored Phase 1 safety study; no new safety signals were identified in the update [3].

What is DS3790 and why is it notable?

DS3790 is a CD37-directed DXd ADC entering first-in-human testing in B-cell NHL with a large global Phase 1/2 design that includes future combinations [5].

What makes ImmunityBio’s study distinct from CAR-T?

It uses off-the-shelf CAR-NK cells plus ANKTIVA and rituximab without lymphodepleting chemotherapy, aiming for outpatient delivery and improved tolerability, building on small prior cohorts [6].

What did Orca Bio report at Tandem?

Retrospective comparisons suggested better survival and GVHD metrics vs PTCy, and a logistics analysis showed 100% delivery within 70 hours; Phase 2 SERENE-T began dosing. Non-randomized design limits interpretation [7].

What expansion is Pfizer seeking for HYMPAVZI?

Priority Review for use in patients ≥6 with inhibitors and children 6–11 without inhibitors. If approved, it would be the first non-factor prophylaxis for children 6–11 with hemophilia B [10].

Entities / Keywords

Exicure; burixafor (GPC-100/TG-0054); CXCR4; G-CSF; ASCT.
Lupin; dasatinib; Sprycel; Ph+ CML; Ph+ ALL; ANDA.
Gilead/Kite; Yescarta; axicabtagene ciloleucel; PCNSL; CAR-T.
Bristol Myers Squibb; Breyanzi; lisocabtagene maraleucel; DTC awareness.
Daiichi Sankyo; DS3790; CD37; DXd ADC.
ImmunityBio; CD19 t-haNK; ANKTIVA (nogapendekin-alfa inbakicept); rituximab; iNHL; Waldenström’s.
Orca Bio; Orca-T; Orca-Q; SERENE-T; PTCy; GVHD; logistics.
CREATE Medicines; in vivo CAR-T; RNA-LNP; NHP; B-cell depletion.
Zydus; desidustat; HIF-PHI; sickle cell disease; ODD.
Pfizer; HYMPAVZI; marstacimab; TFPI; Priority Review; BASIS.