Hematology biweekly video covering 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.
🎯 Watch Our Video Summary Capturing Hematology News from the Last Two Weeks
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- Week 9–15 February 2026
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:08 Yatiri Bio reports blinded AML response prediction for FHD-286 (camibirstat) and signs Foghorn collaboration
0:45 Senti Biosciences completes Phase 1 enrollment for SENTI-202 (CD33/FLT3 logic-gated CAR-NK) in relapsed or refractory AML
1:13 Sanofi rilzabrutinib (Wayrilz) receives FDA Breakthrough Therapy designation and Japan orphan designation for warm autoimmune hemolytic anemia
1:42 Disc Medicine receives FDA Complete Response Letter for bitopertin in erythropoietic protoporphyria, FDA requests ongoing Phase 3 APOLLO results
2:20 Bristol Myers Squibb NDA for iberdomide plus daratumumab and dexamethasone accepted in relapsed or refractory multiple myeloma, action date 17 Aug 2026
2:58 AstraZeneca Calquence (acalabrutinib) plus venetoclax approved in the US as fixed-duration first-line regimen for CLL/SLL
3:23 Ono tirabrutinib NDA accepted for filing for relapsed or refractory primary CNS lymphoma, PDUFA date 18 Dec 2026
3:51 Japan MHLW approves Rituxan (rituximab) for autoimmune hemolytic anemia
4:13 How to reach us
Transcript
Welcome to the latest edition of Hematology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
First, Yatiri Bio reported a blinded retrospective validation of its ProteoCharts platform, using pre-treatment peripheral blood mononuclear cell samples from a Phase 1 trial of Foghorn’s FHD-286, also called camibirstat, in relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes, NCT04891757. Yatiri said ProteoCharts predictions matched observed clinical responses in the blinded set. The company also announced a collaboration with Foghorn that references milestone economics.
Next, Senti Biosciences completed Phase 1 enrollment for SENTI-202, a CD33 and FLT3 logic-gated CAR-NK program, in relapsed or refractory acute myeloid leukemia, NCT06325748. The program has RMAT designation. Senti said it plans FDA discussions in the first half of 2026 for next-stage development, with pivotal design not specified.
Sanofi announced regulatory designations for rilzabrutinib, branded as Wayrilz, a BTK inhibitor, in warm autoimmune hemolytic anemia. Sanofi said the FDA granted Breakthrough Therapy designation in the United States, and Japan granted orphan designation. The designations were based on clinical data from LUMINA 2 Phase 2b, NCT05002777, and Sanofi noted that LUMINA 3 Phase 3 is ongoing, NCT07086976.
Disc Medicine received a Complete Response Letter from the FDA for the bitopertin new drug application in erythropoietic protoporphyria, or EPP. Disc said the FDA indicated it needs results from the ongoing Phase 3 APOLLO study before a decision. The company had sought accelerated approval using whole blood metal-free PPIX as a proposed surrogate, citing AURORA and BEACON, and stated that the FDA acknowledged PPIX lowering and mechanistic plausibility, while noting that a clinical association was not shown in trials as measured.
Bristol Myers Squibb said the FDA accepted its new drug application for iberdomide, a CELMoD, in combination with daratumumab and dexamethasone for relapsed or refractory multiple myeloma. The FDA granted Priority Review and Breakthrough Therapy designation, and set a target action date of 17 Aug 2026. The filing was based on a planned analysis of minimal residual disease negativity rates in the Phase 3 EXCALIBER-RRMM trial, NCT04975997, which is ongoing for progression-free survival.
AstraZeneca said the FDA approved Calquence, acalabrutinib, plus venetoclax in the United States for previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma as a fixed-duration, all-oral regimen. The approval was based on the AMPLIFY Phase 3 trial, NCT03836261, with a fixed duration described as 14 months in the release.
Ono said the FDA accepted its new drug application for tirabrutinib, a BTK inhibitor, in relapsed or refractory primary central nervous system lymphoma, using the accelerated approval pathway. Ono said the submission was supported by the Phase 2 PROSPECT study, with a confirmatory Phase 3 trial recruiting as NCT07104032. The FDA set a PDUFA date of 18 Dec 2026.
Finally, Zenyaku Kogyo and Chugai said Japan’s Ministry of Health, Labour and Welfare approved Rituxan, rituximab, for an additional indication, autoimmune hemolytic anemia. The companies cited a public knowledge-based application route and development requests from Japanese hematology societies.
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Why it matters
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Multiple FDA actions across heme malignancies and rare hematology (NDA accepts, one CRL, one approval) can quickly reshuffle near-term treatment pathways and trial strategies [4–7].
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Surrogate endpoint debates remain central, Disc’s CRL highlights the need for clinical outcome linkage even when biomarker effects are strong (as framed by FDA in the release) [4].
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Fixed-duration, all-oral CLL regimens may shift first-line decision-making and time-on-therapy expectations, depending on uptake and payer policies [6].
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Japan-specific label expansion for rituximab in AIHA formalizes a use already referenced in guidelines, potentially changing access and standardization [8].
🗓️ Explore weekly details and sources
- Week 9 – 15 February 2026
- Week 16–22 February 2026
📚 See the full Hematology archive on our research hub page.
FAQ
What is the regulatory status of rilzabrutinib in wAIHA?
Sanofi said rilzabrutinib received FDA Breakthrough Therapy designation in the US and orphan designation in Japan for warm AIHA, based on LUMINA 2 data and with LUMINA 3 ongoing [3].
Why did Disc Medicine receive a CRL for bitopertin in EPP?
Disc said FDA agreed bitopertin lowered PPIX and noted mechanistic plausibility, but FDA did not see evidence of association between PPIX change and sunlight exposure-based endpoints as measured in AURORA/BEACON, and asked to see Phase 3 APOLLO results [4].
What is iberdomide being filed for, and what is the FDA timeline?
BMS said the NDA is for iberdomide + daratumumab + dexamethasone in RRMM, supported by MRD negativity analysis from EXCALIBER-RRMM, with a target action date of 17 Aug 2026 [5].
What changed for first-line CLL/SLL in the US?
AstraZeneca said the FDA approved Calquence + venetoclax as a fixed-duration, all-oral option for previously untreated CLL/SLL, based on AMPLIFY Phase 3 [6].
What is the US filing milestone for tirabrutinib in PCNSL?
Ono said FDA accepted the NDA for tirabrutinib for relapsed or refractory primary CNS lymphoma under accelerated approval, with a PDUFA date of 18 Dec 2026 and a Phase 3 confirmatory trial recruiting [7].
What did Japan approve for AIHA?
Zenyaku Kogyo and Chugai said Japan’s MHLW approved Rituxan (rituximab) for an additional indication, autoimmune hemolytic anemia, via a public knowledge-based application pathway [8].
Entities / Keywords
Yatiri Bio (ProteoCharts™, AI-driven proteomics, patient stratification)
Foghorn Therapeutics (FHD-286, camibirstat, SMARCA2/SMARCA4, BAF complex)
Senti Biosciences (SENTI-202, logic-gated CAR-NK, CD33, FLT3, RMAT)
Sanofi (rilzabrutinib, Wayrilz, BTK inhibitor, wAIHA, LUMINA 2, LUMINA 3)
Disc Medicine (bitopertin, GlyT1, EPP, PPIX, AURORA, BEACON, APOLLO, CRL)
Bristol Myers Squibb (iberdomide, CELMoD, EXCALIBER-RRMM, MRD, PDUFA)
AstraZeneca (Calquence, acalabrutinib, venetoclax, AMPLIFY, CLL, SLL, fixed-duration)
Ono Pharmaceutical (tirabrutinib, BTK inhibitor, PCNSL, PROSPECT, accelerated approval)
Chugai Pharmaceutical / Zenyaku Kogyo (Rituxan, rituximab, AIHA, MHLW)
