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…
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…
In the randomized, phase 3 BRUIN-CLL-321 trial, pirtobrutinib -- the first and only non-covalent (reversible) BTK inhibitor -- significantly extended progression-free survival compared with standard chemoimmunotherapy options in patients with…
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…
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…
In the randomized, phase 3 BRUIN-CLL-321 trial, pirtobrutinib -- the first and only non-covalent (reversible) BTK inhibitor -- significantly extended progression-free survival compared with standard chemoimmunotherapy options in patients with…
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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.
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.
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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.
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.
Fully Oral Combination of Decitabine/Cedazuridine (ASTX727) Plus Venetoclax for the Treatment of Newly Diagnosed Acute Myeloid Leukemia in Patients Ineligible for Intensive Chemotherapy (Blood, ASH Annual Meeting). DOI 10.1182/blood-2024-198541.
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.
Phase III Trial of Pirtobrutinib Versus Idelalisib/Rituximab or Bendamustine/Rituximab in Covalent Bruton Tyrosine Kinase Inhibitor-Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321) (Journal of Clinical Oncology). DOI 10.1200/JCO-25-00166, PMID 40479620.
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…
CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.