Skip to content
Triangle logo TriangleGet started
← Back to this collection

LABELS · 6df73356-e3c1-498d-af08-c34b5d257bdb

REZLIDHIA

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-11-05
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate corticosteroids and hemodynamic monitoring until symptom resolution. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )
Full extracted label fields
application numbers
  1. NDA215814
boxed warning exact
  1. WARNING: DIFFERENTIATION SYNDROME Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate corticosteroids and hemodynamic monitoring until symptom resolution. ( 5.1 )
brand names
  1. REZLIDHIA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a0c7c8b-b95f-455d-9600-b7351e4397fe
generic names
  1. OLUTASIDENIB
id
6df73356-e3c1-498d-af08-c34b5d257bdb
indications and usage exact
  1. 1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Rigel Pharmaceuticals, Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 71332-005-01
    product ndcs
    1. 71332-005
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2623648
      2. 2623654
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.json
      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
      100
      skip
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%226df73356-e3c1-498d-af08-c34b5d257bdb%22
      spl effective date
      2025-11-05
      spl effective time
      20251105
      spl set id
      4a0c7c8b-b95f-455d-9600-b7351e4397fe
      spl version
      5
      substance names
      1. OLUTASIDENIB
      uniis
      1. 0T4IMT8S5Z
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
      3. individual_indications_not_split_or_reconciled
      Drugs@FDA application source records
      1. application number
        NDA215814
        payload
        all indexed label documents
        1. Appl No
          215814
          Application Docs Date
          2022-12-08 00:00:00
          Application Docs ID
          72821
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        all submission records
        1. Appl No
          215814
          Review Priority
          STANDARD
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2022-12-01 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA215814
        approval interpretation
        Application linkage and approved submission are not indication-level current approval verification
        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2022-12-01
        latest label selection rule
        max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
        latest posted label documents
        1. Appl No
          215814
          Application Docs Date
          2022-12-08 00:00:00
          Application Docs ID
          72821
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        official application record
        Appl No
        215814
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        RIGEL PHARMS
        openfda application present
        true
        products
        1. Active Ingredient
          OLUTASIDENIB
          Appl No
          215814
          Drug Name
          REZLIDHIA
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          150MG
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
      1. NDA215814
      brand names
      1. REZLIDHIA
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      588
      end exclusive
      true
      exact text
      1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as
      label id
      6df73356-e3c1-498d-af08-c34b5d257bdb
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-4ffece9cd8bb5cf0d0ce
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. OLUTASIDENIB
      id
      ind-span-8793a0ad31c214510c44
      label id
      6df73356-e3c1-498d-af08-c34b5d257bdb
      positive predicate support span
      end
      92
      end exclusive
      true
      exact text
      is indicated
      label id
      6df73356-e3c1-498d-af08-c34b5d257bdb
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
      start
      80
      qualifier mentions
      1. context exact
        yeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) wi
        kind
        age
        polarity
        not_inferred
        span
        end
        128
        end exclusive
        true
        exact text
        adult patients
        label id
        6df73356-e3c1-498d-af08-c34b5d257bdb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
        start
        114
      2. context exact
        ukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Phar
        kind
        biomarker
        polarity
        not_inferred
        span
        end
        277
        end exclusive
        true
        exact text
        IDH1) mutation as detected by an FDA-approve
        label id
        6df73356-e3c1-498d-af08-c34b5d257bdb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
        start
        233
      3. context exact
        1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patient
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        67
        end exclusive
        true
        exact text
        Relapsed or Refractory Acute Myeloid Leukem
        label id
        6df73356-e3c1-498d-af08-c34b5d257bdb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
        start
        24
      4. context exact
        IDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        177
        end exclusive
        true
        exact text
        relapsed or refractory acute myeloid leukem
        label id
        6df73356-e3c1-498d-af08-c34b5d257bdb
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
        start
        134
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          388
          end exclusive
          true
          exact text
          1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] .
          label id
          6df73356-e3c1-498d-af08-c34b5d257bdb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%226df73356-e3c1-498d-af08-c34b5d257bdb%22
          spl effective date
          2025-11-05
          spl set id
          4a0c7c8b-b95f-455d-9600-b7351e4397fe
          spl version
          5
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          Source null
          approval pathway
          Source null
          biomarker and test
          Source null
          disease stage
          Source null
          limitations
          Source null
          line
          Source null
          prior therapy
          Source null
          regimen
          Source null
          tumor histology
          Source null
          use intent
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
          1. NDA215814
          brand names
          1. REZLIDHIA
          classification reasons
          1. explicit_positive_indication_predicate
          2. tumor_or_malignant_hematology_words_in_positive_statement
          clinical review status
          pending
          content role
          positive_indication_candidate
          context span
          end
          627
          end exclusive
          true
          exact text
          h a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )
          label id
          6df73356-e3c1-498d-af08-c34b5d257bdb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
          start
          189
          current approval status
          not_reconciled
          duplicate text group
          dup-57b5e99f7329cc0ae8fd
          extraction review status
          automated_candidate_pending_source_review
          generic names
          1. OLUTASIDENIB
          id
          ind-span-9d4f0e4275f03c98b654
          label id
          6df73356-e3c1-498d-af08-c34b5d257bdb
          positive predicate support span
          end
          458
          end exclusive
          true
          exact text
          is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated
          label id
          6df73356-e3c1-498d-af08-c34b5d257bdb
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
          start
          399
          qualifier mentions
          1. context exact
            drogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) wi
            kind
            age
            polarity
            not_inferred
            span
            end
            494
            end exclusive
            true
            exact text
            adult patients
            label id
            6df73356-e3c1-498d-af08-c34b5d257bdb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
            start
            480
          2. context exact
            REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            477
            end exclusive
            true
            exact text
            IDH1) inhibitor indicated for the treatment
            label id
            6df73356-e3c1-498d-af08-c34b5d257bdb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
            start
            433
          3. context exact
            refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
            kind
            biomarker
            polarity
            not_inferred
            span
            end
            615
            end exclusive
            true
            exact text
            IDH1 mutation as detected by an FDA-approved
            label id
            6df73356-e3c1-498d-af08-c34b5d257bdb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
            start
            571
          4. context exact
            nhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an
            kind
            stage_or_setting
            polarity
            not_inferred
            span
            end
            543
            end exclusive
            true
            exact text
            relapsed or refractory acute myeloid leukem
            label id
            6df73356-e3c1-498d-af08-c34b5d257bdb
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
            start
            500
          regulatory links
            schema version
            0.1.0
            source batch sha256
            a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
            source defined aliases
              source span
              end
              621
              end exclusive
              true
              exact text
              REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
              label id
              6df73356-e3c1-498d-af08-c34b5d257bdb
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
              start
              389
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%226df73356-e3c1-498d-af08-c34b5d257bdb%22
              spl effective date
              2025-11-05
              spl set id
              4a0c7c8b-b95f-455d-9600-b7351e4397fe
              spl version
              5
              structured fields status
              not_extracted_no_values_inferred_from_mentions
              structured indication
              age
              Source null
              approval pathway
              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
              line
              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              tumor_directed_candidate
              Passage 3 · unclassified context
              application numbers
              1. NDA215814
              brand names
              1. REZLIDHIA
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              627
              end exclusive
              true
              exact text
              ogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )
              label id
              6df73356-e3c1-498d-af08-c34b5d257bdb
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
              start
              422
              current approval status
              not_reconciled
              duplicate text group
              dup-80a62670eefe5d9fecc8
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. OLUTASIDENIB
              id
              ind-span-cf176d28c675a80e55de
              label id
              6df73356-e3c1-498d-af08-c34b5d257bdb
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                  source defined aliases
                    source span
                    end
                    627
                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    6df73356-e3c1-498d-af08-c34b5d257bdb
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    a4bde797c9bf2daf585a8b4aee4729a720c7cae7da8e5f6a00c3c5ab7d395c3b
                    start
                    622
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%226df73356-e3c1-498d-af08-c34b5d257bdb%22
                    spl effective date
                    2025-11-05
                    spl set id
                    4a0c7c8b-b95f-455d-9600-b7351e4397fe
                    spl version
                    5
                    structured fields status
                    not_extracted_no_values_inferred_from_mentions
                    structured indication
                    age
                    Source null
                    approval pathway
                    Source null
                    biomarker and test
                    Source null
                    disease stage
                    Source null
                    limitations
                    Source null
                    line
                    Source null
                    prior therapy
                    Source null
                    regimen
                    Source null
                    tumor histology
                    Source null
                    use intent
                    unclear

                    Preserved source evidence · Not medical advice