This week’s Hematology update covers key regulatory actions and clinical program progress from the past two weeks. Updates include approvals and filings, trial milestones, and selected partnership or platform developments.
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💊 Iberdomide NDA accepted in RRMM, PDUFA set for 17 Aug 2026 [1] [US • 19 Feb 2026]
Context: Phase 3 EXCALIBER-RRMM (NCT04975997), dual-primary endpoints MRD negativity and PFS, Stage 2 randomizes ~664 patients (open-label) [1].
Key point: FDA accepted NDA for iberdomide + daratumumab + dexamethasone in RRMM, granted Priority Review and Breakthrough Therapy Designation, action date set for 17 Aug 2026 [1].
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Starton doses first patient in Phase 2a STAR-LLD in RRMM [2] [US • 19 Feb 2026]
Context: Randomized dose-escalation Phase 2a comparing continuous SC infusion STAR-LLD vs oral lenalidomide with dexamethasone + proteasome inhibitor, planned n=24 with optional expansion (n stated) [2].
Key point: First patient dosed in Phase 2a evaluating STAR-LLD (continuous delivery lenalidomide) in relapsed/refractory multiple myeloma [2].
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 BEAM-X Phase 2 IIT in MRD-positive AML after allogeneic transplant [3] [Finland • 19 Feb 2026]
Context: Open-label, two-stage Phase 2 IIT with Nordic AML Group, bexmarilimab + azacitidine, primary endpoint MRD negativity at 6 months, n=24, first patient expected Q3 2026 [3].
Key point: Faron announced BEAM-X to evaluate bexmarilimab + azacitidine in post-transplant MRD-positive AML to prevent relapse (MRD setting) [3].
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 TuHURA files IND for TBS-2025 (VISTA mAb) in mutNPM1 r/r AML combo [4] [US • 17 Feb 2026]
Context: Planned Phase 2 (Simon 2-stage) in menin inhibitor-naïve mutNPM1 r/r AML, combination with a menin inhibitor (agent not specified) [4].
Key point: TuHURA filed an FDA IND for TBS-2025 (VISTA-inhibiting antibody), with stated intent to study it in mutNPM1 r/r AML in combination therapy [4].
Implication: Signals pipeline investment and modality expansion.
🐒 Omeros reports successful nonhuman primate OncotoX-AML study [5] [US • 17 Feb 2026]
Context: Nonhuman primate study described as selective, reversible, dose-related reduction in myeloid progenitor cells, and well tolerated (design details not specified) [5].
Key point: Omeros reported primate data for OncotoX-AML and stated it is initiating IND-enabling studies, targeting first-in-human in late 2027 [5].
Implication: Signals pipeline investment and modality expansion.
✅ Calquence + venetoclax approved as fixed-duration 1L regimen in CLL/SLL [6] [US • 20 Feb 2026]
Context: AMPLIFY Phase 3 evaluated fixed-duration Calquence-containing regimens vs chemoimmunotherapy, PFS benefit and safety consistent with known profile (details in source) [6].
Key point: FDA approved Calquence (acalabrutinib) + venetoclax as an all-oral, fixed-duration combination for adult patients with CLL/SLL in the 1L setting [6].
Implication: May influence prescriber choice and payer reviews pending full data.
🇳🇿 Pharmac proposes funding venetoclax combinations for 1L CLL (consultation) [7] [New Zealand • 18 Feb 2026]
Context: Proposal would fund venetoclax + ibrutinib and venetoclax + obinutuzumab for previously untreated CLL from 1 May 2026, consultation open until 4 Mar 2026 [7].
Key point: Pharmac opened consultation on adding funded access to two venetoclax-based combinations as first treatment options for CLL (proposal, not final) [7].
Implication: Introduces competition that may affect pricing and formulary access.
🧠 Tirabrutinib NDA accepted for r/r PCNSL, PDUFA set for 18 Dec 2026 [8] [US • 16 Feb 2026]
https://www.ono-pharma.com/en/news/20250216.html
Context: Filing supported by Phase 2 PROSPECT study (response rates stated in source), confirmatory global Phase 3 trial recruiting (NCT07104032) [8].
Key point: Ono reported FDA acceptance for filing of an NDA (accelerated approval pathway) for tirabrutinib in relapsed/refractory PCNSL, action date set for 18 Dec 2026 [8].
Implication: May influence prescriber choice and payer reviews pending full data.
📊 Fulcrum to present 12-week Phase 1b PIONEER data for pociredir in SCD [9] [US • 17 Feb 2026]
Context: Company scheduled a webcast on 24 Feb 2026 to present 12-week results from the 20 mg cohort (data not included in the release) [9].
Key point: Fulcrum announced it will present 12-week results from the 20 mg cohort of pociredir in sickle cell disease [9].
Implication: May influence prescriber choice and payer reviews pending full data.
🩸 Japan approves Rituxan (rituximab) for autoimmune hemolytic anemia [10] [Japan • 19 Feb 2026]
https://www.chugai-pharm.co.jp/english/news/detail/20260219160000_1228.html
Context: Additional indication approval via public knowledge-based application process in Japan (AIHA) [10].
Key point: Zenyaku Kogyo and Chugai reported MHLW approval of Rituxan for treatment of autoimmune hemolytic anemia [10].
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- FDA actions span both approvals (1L CLL) and late-stage filings (RRMM, PCNSL), setting concrete 2026 decision points [1], [6], [8].
- MRD-directed strategies show up in both myeloma (MRD endpoint referenced for filing) and post-transplant AML trial design [1], [3].
- National payer signals, like Pharmac’s consultation, can rapidly reshape first-line access and prescribing patterns [7].
- Platform innovation continues alongside registrational work, including continuous drug delivery and preclinical AML programs [2], [5].
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FAQ
What is BMS filing iberdomide for, and what is the action date?
BMS reported FDA acceptance of an NDA for iberdomide + daratumumab + dexamethasone in RRMM, with a PDUFA date of 17 Aug 2026 [1].
What did the FDA approve for first-line CLL/SLL in the US?
AstraZeneca reported FDA approval of Calquence (acalabrutinib) + venetoclax as an all-oral, fixed-duration combination for adult patients with CLL/SLL in the 1L setting [6].
What is Ono seeking for tirabrutinib in the US, and when is the PDUFA date?
Ono reported FDA acceptance of an NDA under the accelerated approval pathway for tirabrutinib in relapsed/refractory PCNSL, with a PDUFA date of 18 Dec 2026 [8].
What is BEAM-X testing in post-transplant AML?
Faron described BEAM-X as a Phase 2 IIT evaluating bexmarilimab + azacitidine in MRD-positive AML after allogeneic stem cell transplant, with MRD negativity at 6 months as the primary endpoint [3].
What is Pharmac proposing for first-line CLL access in New Zealand?
Pharmac is consulting on funding venetoclax + ibrutinib and venetoclax + obinutuzumab for previously untreated CLL from 1 May 2026 (proposal) [7].
What is Fulcrum’s near-term SCD catalyst in this set of links?
Fulcrum announced a 24 Feb 2026 webcast to present 12-week data from the 20 mg cohort of Phase 1b PIONEER for pociredir in sickle cell disease [9].
Entities / Keywords
Bristol Myers Squibb; iberdomide; CELMoD; EXCALIBER-RRMM; daratumumab; dexamethasone; MRD.
Starton Therapeutics; STAR-LLD; lenalidomide; continuous subcutaneous infusion; RRMM.
Faron Pharmaceuticals; bexmarilimab; Clever-1; azacitidine; Nordic AML Group; MRD-positive AML; post-transplant.
TuHURA Biosciences; TBS-2025; VISTA; mutNPM1; menin inhibitor; r/r AML; IND.
Omeros; OncotoX-AML; nonhuman primate; IND-enabling.
AstraZeneca; Calquence (acalabrutinib); venetoclax; CLL; SLL; AMPLIFY.
Pharmac; New Zealand; venetoclax; ibrutinib; obinutuzumab; funding proposal.
Ono Pharmaceutical; tirabrutinib; BTK inhibitor; PCNSL; PROSPECT.
Fulcrum Therapeutics; pociredir; PIONEER; sickle cell disease.
Zenyaku Kogyo; Chugai; Rituxan (rituximab); autoimmune hemolytic anemia; MHLW.
References
https://www.ono-pharma.com/en/news/20250216.html
https://www.chugai-pharm.co.jp/english/news/detail/20260219160000_1228.html