Leukemia

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

FDA approves blinatumomab in the consolidation phase of B-cell precursor acute lymphoblastic leukemia, regardless of MRD status

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the randomized, phase 3 ECOG-ACRIN E1910 trial, adding blinatumomab to consolidation chemotherapy significantly extended overall survival compared with chemotherapy alone in adults with MRD-negative B-cell precursor ALL — the…

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Last reviewed

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Evidence stage: Emerging ClinicalRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the single-arm Study ASTX727-07, an all-oral combination of decitabine/cedazuridine (Inqovi) plus venetoclax produced a complete remission rate of 41.6% (and a combined complete-remission-or-partial-hematologic-recovery rate of 52.5%) in older or…

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Last reviewed

Major Advances

FDA approves blinatumomab in the consolidation phase of B-cell precursor acute lymphoblastic leukemia, regardless of MRD status

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the randomized, phase 3 ECOG-ACRIN E1910 trial, adding blinatumomab to consolidation chemotherapy significantly extended overall survival compared with chemotherapy alone in adults with MRD-negative B-cell precursor ALL — the…

Primary source cited

Last reviewed

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Evidence stage: Emerging ClinicalRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the single-arm Study ASTX727-07, an all-oral combination of decitabine/cedazuridine (Inqovi) plus venetoclax produced a complete remission rate of 41.6% (and a combined complete-remission-or-partial-hematologic-recovery rate of 52.5%) in older or…

Primary source cited

Last reviewed

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves blinatumomab in the consolidation phase of B-cell precursor acute lymphoblastic leukemia, regardless of MRD status

Regulatory status: FDA ApprovedEvidence stage: High-Certainty Evidence
Cancer type
Leukemia
Population
Adults 30 to 70 years old with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in measurable-residual-disease-negative (MRD-negative) remission after induction and intensification chemotherapy, randomized to consolidation chemotherapy with or without blinatumomab. The FDA's broader approval also covers pediatric patients (1 month and older) and is not restricted to MRD-negative disease, supported by two additional pediatric relapse trials this record does not independently detail.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults and pediatric patients 1 month and older with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia, in the consolidation phase of multiphase chemotherapy, regardless of measurable residual disease status.
Biomarker requirement
CD19-positive, Philadelphia chromosome-negative
Decision date
2024-06-14

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Regulatory status: FDA ApprovedEvidence stage: Emerging Clinical
Cancer type
Leukemia
Population
Adults 75 years or older, or with comorbidities precluding intensive induction chemotherapy, with newly diagnosed acute myeloid leukemia (AML), enrolled in the single-arm, open-label Study ASTX727-07.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
Decision date
2026-05-13

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

FDA grants traditional approval to pirtobrutinib for BTK-inhibitor-pretreated CLL/SLL

Regulatory status: FDA ApprovedEvidence stage: Later-Stage Human
Cancer type
Leukemia
Population
Adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) previously treated with a covalent BTK inhibitor, randomized to pirtobrutinib or investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab, in the randomized, open-label, phase 3 BRUIN-CLL-321 trial.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with relapsed or refractory CLL/SLL who have previously been treated with a covalent BTK inhibitor.
Decision date
2025-12-03

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

Treatment Innovations

FDA approves the first all-oral combination regimen for older adults with newly diagnosed acute myeloid leukemia

Evidence stage: Emerging ClinicalRegulatory status: FDA Approved
Cancer type
Leukemia
Published
August 13, 2026

In the single-arm Study ASTX727-07, an all-oral combination of decitabine/cedazuridine (Inqovi) plus venetoclax produced a complete remission rate of 41.6% (and a combined complete-remission-or-partial-hematologic-recovery rate of 52.5%) in older or…

Primary source cited

Last reviewed

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Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.