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LABELS · 8aaf7f3e-9dc1-4e71-af62-4943f4284e81

RETEVMO

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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
2026-07-14
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE RETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test ( 1.1 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy ( 1.2 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) ( 1.3 ) Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options ( 1.4 ) 1.1 RET Fusion-Positive Non-Small Cell Lung Cancer RETEVMO ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. 1.2 RET -Mutant Medullary Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. 1.3 RET Fusion-Positive Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 1.4 Other RET Fusion-Positive Solid Tumors RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Full extracted label fields
application numbers
  1. NDA213246
  2. NDA218160
boxed warning exact
    brand names
    1. RETEVMO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fa848ba-a59c-4144-9f52-64d090f4d828
    generic names
    1. SELPERCATINIB
    id
    8aaf7f3e-9dc1-4e71-af62-4943f4284e81
    indications and usage exact
    1. 1 INDICATIONS AND USAGE RETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test ( 1.1 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy ( 1.2 ) Adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate) ( 1.3 ) Adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options ( 1.4 ) 1.1 RET Fusion-Positive Non-Small Cell Lung Cancer RETEVMO ® is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. 1.2 RET -Mutant Medullary Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy. 1.3 RET Fusion-Positive Thyroid Cancer RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 1.4 Other RET Fusion-Positive Solid Tumors RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Eli Lilly and Company
      matched search terms
      1. cancer
      2. tumors
      package ndcs
      1. 0002-3977-60
      2. 0002-2980-60
      3. 0002-2980-26
      4. 0002-5340-60
      5. 0002-6082-60
      6. 0002-6120-60
      7. 0002-5562-60
      product ndcs
      1. 0002-2980
      2. 0002-3977
      3. 0002-5340
      4. 0002-6082
      5. 0002-6120
      6. 0002-5562
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
      1. Indications and Usage Other RET Fusion-Positive Solid Tumors ( 1.4 ) 07/2026 Dosage and Administration ( 2.8 ) 11/2025 Warnings and Precautions ( 5.6 ) 11/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.7 , 5.9 ) 07/2026
      record type
      complete_spl_indications_section_candidate
      routes
      1. ORAL
      rxcuis
      1. 2370164
      2. 2370170
      3. 2370172
      4. 2370174
      5. 2679805
      6. 2679808
      7. 2679810
      8. 2679812
      9. 2679813
      10. 2679814
      11. 2679815
      12. 2679816
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00500.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
      500
      total
      830
      sha256
      424ccf5bc67db0a96ee2c35ed913dd5894642716182773d81ca19cdfb9ba32f3
      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=500&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%228aaf7f3e-9dc1-4e71-af62-4943f4284e81%22
      spl effective date
      2026-07-14
      spl effective time
      20260714
      spl set id
      7fa848ba-a59c-4144-9f52-64d090f4d828
      spl version
      23
      substance names
      1. SELPERCATINIB
      uniis
      1. CEGM9YBNGD
      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
      4. fda_label_posted_after_spl_effective_date_requires_version_review
      Drugs@FDA application source records
      1. application number
        NDA213246
        payload
        all indexed label documents
        1. Appl No
          213246
          Application Docs Date
          2020-05-08 00:00:00
          Application Docs ID
          62880
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          213246
          Application Docs Date
          2021-02-01 00:00:00
          Application Docs ID
          66043
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          213246
          Application Docs Date
          2022-09-28 00:00:00
          Application Docs ID
          72176
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        4. Appl No
          213246
          Application Docs Date
          2022-09-28 00:00:00
          Application Docs ID
          72177
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
          Submission Type
          SUPPL
        5. Appl No
          213246
          Application Docs Date
          2024-04-11 00:00:00
          Application Docs ID
          78108
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          10
          Submission Type
          SUPPL
        6. Appl No
          213246
          Application Docs Date
          2024-05-29 00:00:00
          Application Docs ID
          78568
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          12
          Submission Type
          SUPPL
        7. Appl No
          213246
          Application Docs Date
          2024-06-13 00:00:00
          Application Docs ID
          78783
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        8. Appl No
          213246
          Application Docs Date
          2024-09-30 00:00:00
          Application Docs ID
          79764
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          11
          Submission Type
          SUPPL
        9. Appl No
          213246
          Application Docs Date
          2024-09-30 00:00:00
          Application Docs ID
          79765
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        10. Appl No
          213246
          Application Docs Date
          2024-12-19 00:00:00
          Application Docs ID
          80640
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          14
          Submission Type
          SUPPL
        11. Appl No
          213246
          Application Docs Date
          2025-11-21 00:00:00
          Application Docs ID
          84264
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        12. Appl No
          213246
          Application Docs Date
          2025-11-21 00:00:00
          Application Docs ID
          84265
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          16
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2026-07-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          16
          Submission Status
          AP
          Submission Status Date
          2025-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          213246
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2025-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          14
          Submission Status
          AP
          Submission Status Date
          2024-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          213246
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2024-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          213246
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2024-05-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          11
          Submission Status
          AP
          Submission Status Date
          2024-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2024-04-10 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2024-06-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          213246
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2022-09-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2022-09-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          213246
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2021-01-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA213246
        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
        2026-07-14
        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
          213246
          Application Docs Date
          2026-07-29 00:00:00
          Application Docs ID
          86729
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        official application record
        Appl No
        213246
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ELI LILLY AND CO
        openfda application present
        true
        products
        1. Active Ingredient
          SELPERCATINIB
          Appl No
          213246
          Drug Name
          RETEVMO
          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          40MG
          marketing status
          1. Prescription
        2. Active Ingredient
          SELPERCATINIB
          Appl No
          213246
          Drug Name
          RETEVMO
          Form
          CAPSULE;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          80MG
          marketing status
          1. Prescription
      2. application number
        NDA218160
        payload
        all indexed label documents
        1. Appl No
          218160
          Application Docs Date
          2024-04-10 00:00:00
          Application Docs ID
          78105
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          218160
          Application Docs Date
          2024-06-12 00:00:00
          Application Docs ID
          78778
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        3. Appl No
          218160
          Application Docs Date
          2024-09-30 00:00:00
          Application Docs ID
          79766
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        4. Appl No
          218160
          Application Docs Date
          2024-09-30 00:00:00
          Application Docs ID
          79767
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        5. Appl No
          218160
          Application Docs Date
          2024-12-19 00:00:00
          Application Docs ID
          80639
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
          SUPPL
        6. Appl No
          218160
          Application Docs Date
          2025-11-21 00:00:00
          Application Docs ID
          84266
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5
          Submission Type
          SUPPL
        7. Appl No
          218160
          Application Docs Date
          2025-11-21 00:00:00
          Application Docs ID
          84267
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        8. Appl No
          218160
          Application Docs Date
          2026-07-29 00:00:00
          Application Docs ID
          86730
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          12
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-04-10 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-06-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          218160
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2024-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2024-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2024-12-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2025-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          218160
          Review Priority
          PRIORITY
          Submission Class Code ID
          2
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2025-11-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          218160
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2026-07-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA218160
        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
        2026-07-14
        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
          218160
          Application Docs Date
          2026-07-29 00:00:00
          Application Docs ID
          86730
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          7
          Submission Type
          SUPPL
        official application record
        Appl No
        218160
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ELI LILLY AND CO
        openfda application present
        true
        products
        1. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          40MG
          marketing status
          1. Prescription
        2. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          80MG
          marketing status
          1. Prescription
        3. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          0
          Strength
          120MG
          marketing status
          1. Prescription
        4. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          TABLET;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          1
          Strength
          160MG
          marketing status
          1. Prescription
        5. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          CAPSULE;ORAL
          Product No
          005
          Reference Drug
          0
          Reference Standard
          0
          Strength
          40MG
          marketing status
          1. Prescription
        6. Active Ingredient
          SELPERCATINIB
          Appl No
          218160
          Drug Name
          RETEVMO
          Form
          CAPSULE;ORAL
          Product No
          006
          Reference Drug
          0
          Reference Standard
          0
          Strength
          80MG
          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. NDA213246
      2. NDA218160
      brand names
      1. RETEVMO
      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
      474
      end exclusive
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                    r metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). 1.4 Other RET Fusion-Positive Solid Tumors RETEVMO is indicated for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
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                      Preserved source evidence · Not medical advice