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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of  Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutationResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of  Rezlidhia (olutasidenib) for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation
  
  	
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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide another quick update on a recent FDA cancer drug approval.

On December 1, 2022, the FDA approved olutasidenib (brand name Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible *IDH1* mutation as detected by an FDA-approved test.

On the same day, the FDA also approved the Abbott RealTime IDH1 Assay to select patients for olutasidenib.

Approval was based on Study 2102-HEM-101, an open-label, single-arm, multicenter clinical trial that included 147 adult patients with relapsed or refractory acute myeloid leukemia with an IDH1 mutation confirmed using the above assay. Olutasidenib was given orally, 150 mg twice daily, until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation. The median treatment duration was 4.7 months. Sixteen patients underwent hematopoietic stem cell transplantation following olutasidenib.

Efficacy was established on the rate of complete remission plus complete remission with partial hematologic recovery, the duration of complete remission plus complete remission with partial hematologic recovery, and the rate of conversion from transfusion dependence to independence. The complete remission plus complete remission with partial hematologic recovery rate was 35%, including 32% complete remission and 2.7% complete remission with partial hematologic recovery. The median time to complete remission plus complete remission with partial hematologic recovery was 1.9 months, and the median duration of complete remission plus complete remission with partial hematologic recovery was 25.9 months.

Among the 86 patients who were dependent on red blood cell and/or platelet transfusions at baseline, 29 became independent of red blood cell and platelet transfusions during any 56-day post-baseline period. Of the 61 patients who were independent of both red blood cell and platelet transfusions at baseline, 39 remained transfusion independent during any 56-day post-baseline period.

Prescribing information contains a Boxed Warning alerting health care professionals and patients about the risk of differentiation syndrome which can be fatal.

Full prescribing information for these approvals can be found at Drugs@FDA: FDA-Approved Drugs.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback to FDAOncology@fda.hhs.gov. Thanks for tuning into the D.I.S.C.O. Burst Edition.

                                                                                  Content current as of:
      01/10/2023Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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