Acute megakaryoblastic leukemia

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At a Glance

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Regulatory Watchboard

4 events
May 2022Tibsovo: FDA approved

In combination with azacitidine or as monotherapy for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

FDAcompleted
Nov 2018

XOSPATA: FDA approved

XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.

FDAcompleted
Nov 2018

DAURISMO: FDA approved

DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are >75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.

FDAcompleted
Aug 2017Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

Roswell Park Cancer Institute — PHASE1

TrialACTIVE NOT RECRUITING

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

2 programs

FINANCIAL LANDSCAPE SUMMARY

2

Total programs

2

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Patient Assistance Programs2

DAURISMO

Pfizer, Inc.

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Idamycin

Adria Laboratories, Inc.

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Approved Treatments

4 FDA-approved

Tibsovo

(IVOSIDENIB)Orphan drug

Servier Pharmaceutical LLC

Isocitrate Dehydrogenase 1 Inhibitor [EPC]

12.1 Mechanism of Action Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. In patients with A...

Approved May 2022FDA label ↗

XOSPATA

(gilteritinib)Orphan drug

Astellas Pharma US, Inc.

12.1 Mechanism of Action Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3...

Approved Nov 2018FDA label ↗

DAURISMO

(Glasdegib)Orphan drug

Pfizer, Inc.

Hedgehog Pathway Inhibitor [EPC]

12.1 Mechanism of Action Glasdegib is an inhibitor of the Hedgehog pathway. Glasdegib binds to and inhibits Smoothened, a transmembrane protein involv...

Approved Nov 2018FDA label ↗

Idamycin

(Idarubicin HCl for injection)Orphan drugstandard

Adria Laboratories, Inc.

12.1 Mechanism of Action Idarubicin hydrochloride has antimitotic and cytotoxic activity through forming complexes with the DNA, inhibiting nucleic ac...

FDA label ↗

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Clinical Trial Landscape

No active clinical trials currently recruiting for Acute megakaryoblastic leukemia.
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Recent News & Research

6 articles
Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhiApr 16, 2026

[Acute megakaryoblastic leukemia with CBFA2T3::GLIS2 fusion gene: 3 cases report and literature review].

This study retrospectively analyzed the clinical manifestations, genetic characteristics, treatment courses, and prognoses of patients with pediatric acute megakaryoblastic leukemia (AMKL) with CBFA2T...

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EJHaemApr 10, 2026

Identification of an Elusive CBFA2T3::GLIS2 Fusion Variant in Acute Megakaryoblastic Leukemia by Whole Genome Sequencing.

Advancements in genomic profiling have significantly improved the classification and treatment strategies for acute myeloid leukemia (AML). However, widely utilized molecular diagnostic techniques, in...

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Trends in molecular medicineApr 9, 2026

BH3 mimetic therapies for CBFA2T3::GLIS2 pediatric acute megakaryoblastic leukemia.

Pediatric acute megakaryoblastic leukemia (AMKL) associated with the CBFA2T3::GLIS2 (CG2) gene fusion is distinctive by virtue of its aggressiveness and ability to transform normal cells in a single e...

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BloodApr 8, 2026

Polycomb repressive complex 2 insufficiency underlies myeloid leukemia in Down syndrome.

Children with Down syndrome (DS) have an elevated risk of developing myeloid leukemia in DS (ML-DS). In addition to mutations in GATA1, which generate the truncated isoform GATA1-short (GATA1s), ML-DS...

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BMC pediatricsMar 27, 2026

Acute megakaryoblastic leukemia with myeloid sarcoma among a pediatric patient harbouring RBM15::MRTFA: a case report and literature review.

Acute megakaryoblastic leukemia with myeloid sarcoma among a pediatric patient harbouring RBM15::MRTFA: a case report and literature review.

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International journal of hematologyMar 24, 2026

Acute megakaryoblastic leukemia with RBM15::MKL1 fusion presenting as neonatal acute liver failure: rescued by living-donor liver transplantation.

Acute liver failure in the neonatal period is commonly caused by infections, metabolic disorders, immune disorders, or neonatal hepatitis-like diseases of unknown etiology; however, malignant diseases...

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Specialist Network

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