Dr. Donnellan Reflects on FDA Approvals in Acute Leukemia

William B. Donnellan, MD
Published: Friday, Mar 02, 2018



William B. Donnellan, MD, investigator, Hematologic Malignancies, Sarah Cannon Research Institute, Tennessee Oncology, reflects on some of the most pivotal FDA approvals in acute leukemia in the past year.

Donnellan says that 2017 was a blockbuster year for drug approvals in acute leukemia. August 2017 brought about a few FDA approvals for the treatment of patients with acute leukemia, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

Enasidenib (Idhifa) as a treatment for patients with relapsed or refractory IDH2-mutated AML, based on a phase I/II study that showed a complete remission rate of 19.3 in this patient population. Also in AML, CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes was approved by the FDA.

In ALL, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute ALL, based on findings from the phase III INO-VATE trial. And rounding out August, tisagenlecleucel (Kymriah) was approved for the treatment of patients up to 25 years of age with B-cell precursor ALL.


William B. Donnellan, MD, investigator, Hematologic Malignancies, Sarah Cannon Research Institute, Tennessee Oncology, reflects on some of the most pivotal FDA approvals in acute leukemia in the past year.

Donnellan says that 2017 was a blockbuster year for drug approvals in acute leukemia. August 2017 brought about a few FDA approvals for the treatment of patients with acute leukemia, such as acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

Enasidenib (Idhifa) as a treatment for patients with relapsed or refractory IDH2-mutated AML, based on a phase I/II study that showed a complete remission rate of 19.3 in this patient population. Also in AML, CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes was approved by the FDA.

In ALL, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute ALL, based on findings from the phase III INO-VATE trial. And rounding out August, tisagenlecleucel (Kymriah) was approved for the treatment of patients up to 25 years of age with B-cell precursor ALL.



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