Subscribe

Tibsovo Now FDA Approved as First-Line Treatment for AML with IDH1 Mutation

Web Exclusives - FDA Approvals, In the News
Yvette Florio Lane

On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.

This is the second FDA approval for ivosidenib, which was previously approved on July 20, 2018, for the treatment of patients with relapsed or refractory AML with a susceptible IDH1 mutation.

The most recent approval of this agent was based on results from the open-label, single-arm, multicenter, clinical trial that included 28 patients with newly diagnosed AML with an IDH1 mutation.

Patients were treated with ivosidenib, which was administered orally at a dose of 500 mg daily until disease progression, development of unacceptable toxicity, or stem-cell transplantation. The primary end point of the trial was the combined complete remission (CR) and complete remission with partial hematologic improvement (CRh) rate.

Twelve (42.9%) of the 28 patients achieved CR+CRh, and 7 (41.2%) of the 17 transfusion-dependent patients achieved transfusion independence lasting ≥8 weeks. Two of the 28 patients underwent stem-cell transplantation following ivosidenib treatment.

Adverse reactions occurring in ≥25% of patients included diarrhea, fatigue, edema, decreased appetite, leukocytosis, nausea, arthralgia, abdominal pain, dyspnea, differentiation syndrome, and myalgia.

The prescribing information for ivosidenib includes a boxed warning that differentiation syndrome may occur and can be fatal if not treated.

Related Items
FDA Approvals of Brand-Name Prescription Drugs, January 1, 2019, Through June 15, 2020
August 2020 Vol 13, Eleventh Annual Payers' Guide published on September 9, 2020 in FDA Approvals
Imbruvica (Ibrutinib) Receives Expanded Indication, in Combination with Rituximab, as First-Line Treatment for Chronic Lymphocytic Leukemia
August 2020 Vol 13, Eleventh Annual Payers' Guide published on September 9, 2020 in FDA Approvals
Mayzent (Siponimod) Approved for Relapsing Forms of Multiple Sclerosis, Including Active Secondary Progressive Disease
August 2020 Vol 13, Eleventh Annual Payers' Guide published on September 9, 2020 in FDA Approvals
Pemazyre (Pemigatinib) First Targeted Therapy FDA Approved for Cholangio­carcinoma with FGFR2 Biomarker
August 2020 Vol 13, Eleventh Annual Payers' Guide published on September 9, 2020 in FDA Approvals
Tazverik (Tazemetostat) First FDA-Approved Treatment Specifically for Patients with Epithelioid Sarcoma
August 2020 Vol 13, Eleventh Annual Payers' Guide published on September 9, 2020 in FDA Approvals
Last modified: June 3, 2019
Copyright © Engage Healthcare Communications, LLC. All rights reserved.