Hematology Today—February 2, 2026

LucidQuest

4 hours ago

This weekly update in Hematology covers regulatory actions, late-stage clinical progress, guideline updates, and real-world evidence, including approvals, designations, and digital health developments.

In Today’s Newsletter

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💉 D-VRd approved for transplant-ineligible NDMM [1] [US • 27 Jan 2026]

https://www.jnj.com/media-center/press-releases/darzalex-faspro-based-quadruplet-regimen-approved-in-the-u-s-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible
Context: CEPHEUS Ph3 compared D-VRd vs VRd in NDMM ineligible or deferring ASCT, MRD-negativity primary endpoint.
Key point: FDA approved daratumumab/hyaluronidase-fihj + bortezomib/lenalidomide/dexamethasone with higher MRD-negativity, deeper responses, and improved PFS vs VRd.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Innovent IBI3003 gets US Fast Track in R/R MM [2] [27 Jan 2026]

https://en.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=577
Context: GPRC5D/BCMA/CD3 tri-specific TCE; Ph1/2 in China and Australia, US Ph1/2 planned. Early ASH 2025 data reported.
Key point: Fast Track for patients after ≥4 prior lines including PI, IMiD, anti-CD38; higher-dose cohort showed promising ORR with manageable CRS/ICANS.
Implication: Signals pipeline investment and modality expansion.

🧪 Orphan Drug for CTD402 in R/R T-ALL/LBL [3] [27 Jan 2026]

https://finance.yahoo.com/news/imviva-biotech-receives-fda-orphan-133000349.html
Context: Allogeneic anti-CD7 CAR-T; TENACITY-01 global Ph1b/2 enrolling adolescents and adults, single-arm, open-label.
Key point: FDA granted Orphan Drug designation; company cites early CR and MRD-negative rates in ongoing study.
Implication: Signals pipeline investment and modality expansion.

🇨🇦 Jaypirca available in Canada for R/R MCL and CLL/SLL [4] [CA • 27 Jan 2026]

https://www.newswire.ca/news-releases/jaypirca-r-pirtobrutinib-the-first-and-only-non-covalent-reversible-btk-inhibitor-now-available-in-canada-for-adult-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-and-chronic-lymphocytic-leukemia-874020368.html
Context: NOC/c based on BRUIN Ph1/2 monotherapy cohorts post covalent BTKi, with defined ORR and DOR.
Key point: Pirtobrutinib, a non-covalent BTK inhibitor, approved for R/R MCL and for CLL/SLL after specified prior therapies.
Implication: Introduces competition that may affect pricing and formulary access.

🧯 NCCN lists ropeginterferon alfa-2b-njft as Category 1 preferred in high-risk ET (investigational) [5] [US • 27 Jan 2026]

https://us.pharmaessentia.com/pharmaessentia-announces-updated-nccn-clinical-practice-guidelines-include-ropeginterferon-alfa-2b-njft-besremi-for-treatment-of-essential-thrombocythemia-et/
Context: BESREMi is FDA-approved for PV; sBLA to add ET under FDA review.
Key point: NCCN updated guidelines to include ropeginterferon alfa-2b-njft as Category 1 preferred for high-risk ET with inadequate or lost response.
Implication: May influence prescriber choice and payer reviews pending full data.

🛡️ Breakthrough Therapy for NXC-201 in R/R AL amyloidosis [6] [US • 28 Jan 2026]

https://immixbio.com/immix-biopharma-receives-u-s-fda-breakthrough-therapy-designation-for-nxc-201/
Context: BCMA-targeted CAR-T with RMAT and ODD; ongoing US Ph2 NEXICART-2, registrational design.
Key point: FDA BTD based on ASH 2025 interim results; company plans final dataset and BLA submission this year.
Implication: Signals pipeline investment and modality expansion.

🦴 Hemophilia linked to higher fracture risk in Canadian cohort [7] [30 Jan 2026]

https://hemophilianewstoday.com/news/bone-fracture-risk-higher-people-hemophilia-canadian-study/
Context: Registry-based matched cohort study from Canada, published in Haemophilia.
Key point: People with hemophilia had a 46% higher fracture risk vs controls, higher with severe disease and inhibitor history.
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

📱 florio HAEMO shows usability and ABR reductions [8] [27 Jan 2026]

https://hemophilianewstoday.com/news/digital-tool-help-people-hemophilia-live-normal-life/
Context: App plus clinician dashboard to track treatment, factor levels, activity; multi-country rollout since 2020.
Key point: Early evaluations report high acceptance and reduced annualized bleeding rates, with real-time factor level estimates to plan activities.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🩸 Spurs ticket drive to boost blood donations during freeze [9] [US • 26 Jan 2026]

https://spectrumlocalnews.com/tx/south-texas-el-paso/news/2026/01/26/spurs-offer-free-tickets-to-blood-donors
Context: Winter weather lowered donations in South Texas; community campaign with South Texas Blood & Tissue.
Key point: Donors Jan 26–29 receive a free ticket for Feb 1 Spurs vs Magic with promo code TICKET.
Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

Frontline D-VRd now covers NDMM regardless of transplant eligibility, likely shifting standards [1].
New T-cell engagers and allogeneic CAR-T aim at post-CD38 and T-cell malignancy gaps [2–3].
Non-covalent BTK inhibition offers an option post cBTKi and BCL-2 inhibitor exposure in Canada [4].
NCCN ET update may prime access for interferon if FDA expands label [5].
BTD for AL amyloidosis reflects urgency where approved disease-modifying options are limited [6].
RWE flags bone health risks in hemophilia, while digital tools target personalized, activity-aligned care [7–8].
Blood supply initiatives directly support transfusion-dependent patients [9].

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FAQ

What did FDA approve for multiple myeloma?

Daratumumab and hyaluronidase-fihj plus bortezomib/lenalidomide/dexamethasone for newly diagnosed, transplant-ineligible adults, based on CEPHEUS MRD and PFS findings [1].

Which patients are covered by Innovent’s Fast Track for IBI3003?

R/R MM after at least four prior lines including a PI, an IMiD, and anti-CD38 therapy. Early efficacy comes from Ph1/2 cohorts, details vary by dose level [2].

What does Orphan Drug designation mean for Imviva’s CTD402?

Incentives like potential exclusivity and fee waivers for a rare disease therapy. Efficacy remains under study in TENACITY-01, a single-arm Ph1b/2 trial [3].

Is pirtobrutinib fully approved in Canada?

Authorized under a Notice of Compliance with conditions for specified R/R MCL and CLL/SLL populations, based on BRUIN ORR pending confirmatory data [4].

Can clinicians use ropeginterferon for ET now?

NCCN lists it as Category 1 preferred for certain high-risk ET, but ET label expansion is under FDA review, so adoption may vary by institution and payer [5].

What does BTD imply for NXC-201?

Enhanced FDA interaction to expedite development and review. Approval still depends on adequate safety and efficacy from NEXICART-2 and subsequent filings [6].

Entities / Keywords

Daratumumab/hyaluronidase-fihj (DARZALEX FASPRO; J&J) • D-VRd • CEPHEUS • MRD • PFS • Innovent IBI3003 • GPRC5D • BCMA • Tri-specific TCE • Imviva CTD402 • Anti-CD7 CAR-T • T-ALL/LBL • Pirtobrutinib (Jaypirca; Lilly) • BTK inhibitor • BRUIN • Ropeginterferon alfa-2b-njft (BESREMi; PharmaEssentia) • Essential thrombocythemia • NCCN Category 1 • NXC-201 (Immix Biopharma) • AL amyloidosis • BTD • RMAT • Hemophilia fractures • florio HAEMO • Blood donation campaign