Hematology Today—June 22, 2026

LucidQuest

1 day ago

This week’s Hematology update highlights regulatory milestones, advancing late-stage and early-phase clinical programs, new market launches, and expanding global access across blood cancers and hematologic disorders.

In Today’s Newsletter

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💊 Aptose TUSCANY tuspetinib triplet [1] [Europe • 15 Jun 2026]

https://www.aptose.com/news-media/press-releases/detail/347/aptose-presents-safety-response-and-mrd-clinical-data
Context: Aptose presented EHA 2026 data from TUSCANY, a Phase 1/2 study of tuspetinib plus venetoclax and azacitidine in newly diagnosed AML patients ineligible for induction chemotherapy.
Key point: The triplet showed an 86.2% composite complete response rate in evaluable patients and MRD negativity in 86.2% of CR/CRh patients.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Halia ofirnoflast Fast Track in lower-risk MDS [2] [US • 15 Jun 2026]

https://haliatx.com/news/halia-therapeutics-receives-fda-fast-track-designation-for-ofirnoflast-ht-6184-in-lower-risk-myelodysplastic-syndromes
Context: Ofirnoflast (HT-6184) is an oral NEK7 allosteric modulator designed to regulate NLRP3 inflammasome biology in lower-risk MDS.
Key point: FDA granted Fast Track designation after Phase 2 data showed durable transfusion independence and multilineage hematologic improvement.
Implication: May influence prescriber choice and payer reviews pending full data.

🩸 Sumitomo nuvisertib plus momelotinib in myelofibrosis [3] [Europe • 15 Jun 2026]

https://news.us.sumitomo-pharma.com/press-release-details/2026/Sumitomo-Pharma-America-Announces-Encouraging-Clinical-and-Translational-Data-at-EHA-2026-Highlighting-Investigational-Combination-Therapy-in-RelapsedRefractory-Myelofibrosis-and-New-Research-Findings-in-Menin-Inhibition-in-Leukemia/default.aspx
Context: Sumitomo Pharma America presented EHA 2026 data on nuvisertib plus momelotinib in relapsed or refractory myelofibrosis with anemia.
Key point: Preliminary Phase 1/2 data showed clinical activity across spleen, symptom, and anemia measures, with 60% of evaluable patients achieving triple response at Week 24.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Deciphera INTREPID Phase 3 starts in PV [4] [US • 17 Jun 2026]

https://www.deciphera.com/news/deciphera-pharmaceuticals-announces-first-patient-dosed-pivotal-phase-3-intrepid-study
Context: INTREPID is a pivotal global Phase 3 study evaluating sapablursen in phlebotomy-dependent polycythemia vera.
Key point: Deciphera, an Ono Pharmaceutical company, announced the first patient dosed; the primary endpoint is response defined by absence of phlebotomy eligibility.
Implication: May influence prescriber choice and payer reviews pending full data.

🛡️ Akeso ligufalimab combo in frontline AML [5] [Europe • 17 Jun 2026]

http://biospace.com/press-releases/ligufalimab-cd47-based-combination-achieves-deep-responses-and-survival-benefit-in-frontline-aml-phase-ii-results-presented-in-oral-session-at-eha-2026
Context: Akeso presented randomized Phase 2 EHA 2026 results for ligufalimab (AK117), an anti-CD47 antibody, plus azacitidine and venetoclax in treatment-naïve AML patients ineligible for intensive chemotherapy.
Key point: The ligufalimab arm showed longer event-free survival and overall survival trends versus control, with higher MRD-negative CRc and no new safety signals reported.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 Avenacy launches bortezomib injection in the US [6] [US • 17 Jun 2026]

https://www.businesswire.com/news/home/20260617268531/en/Avenacy-Announces-Launch-of-Bortezomib-for-Injection-in-the-U.S.-Market
Context: Avenacy launched Bortezomib for Injection, which contains the same active ingredient as VELCADE.
Key point: The product is indicated for adults with multiple myeloma and mantle cell lymphoma and is available as a 3.5 mg single-dose vial.
Implication: Introduces competition that may affect pricing and formulary access.

🔬 Roche Lunsumio VELO plus Polivy sBLA accepted [7] [US • 18 Jun 2026]

https://www.roche.com/media/releases/med-cor-2026-06-18
Context: Roche’s sBLA covers subcutaneous Lunsumio VELO (mosunetuzumab) plus Polivy (polatuzumab vedotin) for adults with relapsed or refractory LBCL after at least one prior systemic therapy.
Key point: FDA accepted the filing based on Phase 3 SUNMO data; the agency decision date is expected by 09 Feb 2027.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 IASO Bio FUCASO approved in Singapore [8] [Singapore • 18 Jun 2026]

https://www.iasobio.com/info.php?id=309
Context: Equecabtagene autoleucel (FUCASO) is a fully human anti-BCMA CAR-T therapy for relapsed or refractory multiple myeloma.
Key point: Singapore HSA approved the therapy for adults after at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Implication: May expand screening, initiation, and follow-up at scale.

🇯🇵 Incyte Japan Minjuvi approved in R/R DLBCL [9] [Japan • 18 Jun 2026]

https://www.businesswire.com/news/home/20260618308888/en/Incyte-Japan-Announces-Approval-of-Minjuvi-tafasitamab-in-Combination-with-Lenalidomide-for-the-Treatment-of-Adults-with-Relapsed-or-Refractory-Diffuse-Large-B-Cell-Lymphoma-DLBCL
Context: Minjuvi (tafasitamab) is a CD19-targeting monoclonal antibody evaluated with lenalidomide in L-MIND and J-MIND.
Key point: Japan’s MHLW approved Minjuvi plus lenalidomide for adults with relapsed or refractory DLBCL.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Sanofi Sarclisa SC approved in Japan [10] [Japan • 19 Jun 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-19-10-31-15-3314694
Context: Sarclisa (isatuximab) subcutaneous formulation was approved in Japan in combination with approved standard-of-care regimens for multiple myeloma.
Key point: Approval was based on multiple studies, including IRAKLIA Phase 3, which showed non-inferiority versus intravenous Sarclisa for efficacy and pharmacokinetics.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

Why it matters

AML remains highly active, with Aptose and Akeso both positioning triplet or antibody-based combinations around depth of response, MRD, and survival signals.
Myelofibrosis and polycythemia vera updates show continued investment in anemia, hepcidin, and phlebotomy-reduction strategies.
Regulatory activity in Japan and Singapore points to wider Asia access for lymphoma, myeloma, and CAR-T therapies.
Roche’s LBCL filing reinforces the push toward outpatient-ready, chemotherapy-free regimens in community-accessible lymphoma care.
Avenacy’s bortezomib launch adds another injectable oncology product to the US supply landscape.

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FAQ

What is Aptose’s tuspetinib triplet being tested for?

Aptose is testing tuspetinib plus venetoclax and azacitidine in newly diagnosed AML patients ineligible for induction chemotherapy. The EHA update reported high composite complete response and MRD-negative response rates. [1]

What did FDA Fast Track mean for Halia’s ofirnoflast?

FDA Fast Track may support more frequent FDA interactions and potential expedited review options if criteria are met. Halia received the designation for adult patients with lower-risk MDS. [2]

What is Deciphera’s INTREPID study measuring?

INTREPID is evaluating sapablursen versus placebo in phlebotomy-dependent polycythemia vera. The primary endpoint is response, defined by absence of phlebotomy eligibility. [4]

Why is Roche’s Lunsumio VELO plus Polivy filing notable?

Roche is seeking approval for subcutaneous Lunsumio VELO plus Polivy in relapsed or refractory LBCL after at least one prior therapy. The source frames it as outpatient-ready and relevant for community access. [7]

Which Asia regulatory approvals stood out this week?

IASO Bio received Singapore HSA approval for FUCASO in relapsed or refractory multiple myeloma, Incyte Japan received MHLW approval for Minjuvi plus lenalidomide in R/R DLBCL, and Sanofi received Japan approval for Sarclisa SC in multiple myeloma. [8][9][10]

What does Avenacy’s bortezomib launch add?

Avenacy launched Bortezomib for Injection in the US for adults with multiple myeloma and mantle cell lymphoma. The company said the product will ship to wholesale partners. [6]

Entities / Keywords

Acute myeloid leukemia, AML, newly diagnosed AML, frontline AML
Tuspetinib, TUSCANY, Aptose Biosciences, venetoclax, azacitidine
Ofirnoflast, HT-6184, Halia Therapeutics, lower-risk MDS, NEK7, NLRP3 inflammasome
Nuvisertib, momelotinib, Sumitomo Pharma America, relapsed or refractory myelofibrosis
Sapablursen, Deciphera Pharmaceuticals, Ono Pharmaceutical, INTREPID, polycythemia vera, TMPRSS6, hepcidin
Ligufalimab, AK117, Akeso, CD47, azacitidine, venetoclax
Bortezomib for Injection, Avenacy, VELCADE, multiple myeloma, mantle cell lymphoma
Lunsumio VELO, mosunetuzumab, Polivy, polatuzumab vedotin, Roche, SUNMO, LBCL, DLBCL
Equecabtagene autoleucel, FUCASO, IASO Bio, BCMA CAR-T, Singapore HSA
Minjuvi, tafasitamab, Incyte Japan, lenalidomide, L-MIND, J-MIND
Sarclisa, isatuximab, Sanofi, subcutaneous formulation, IRAKLIA, Japan MHLW