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LABELS · a46c4cd4-282a-4920-9372-759f83c286fa

Vectibix

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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
2026-06-23
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DERMATOLOGIC TOXICITY See full prescribing information for complete boxed warning . Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy. ( 2.3 , 5.1 , 6.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1 , 14.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)* In combination with sotorasib, for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1 ) *Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown ( 1 , 2.1 , 5.2 , 12.1 , 14.3 ). Metastatic Colorectal Cancer (mCRC) RAS Wild-Type mCRC Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC) [see Dosage and Administration (2.1) ] : As first-line therapy in combination with FOLFOX [see Clinical Studies (14.2) ] . As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see Clinical Studies (14.1) ] . KRAS G12C -mutated mCRC Vectibix, in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.4) ] . Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] .
Full extracted label fields
application numbers
  1. BLA125147
boxed warning exact
  1. WARNING: DERMATOLOGIC TOXICITY Dermatologic Toxicity: Dermatologic toxicities occurred in 90% of patients and were severe (NCI-CTC Grade 3 and higher) in 15% of patients receiving Vectibix monotherapy [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: DERMATOLOGIC TOXICITY See full prescribing information for complete boxed warning . Dermatologic toxicities were reported in 90% of patients and were severe in 15% of patients receiving monotherapy. ( 2.3 , 5.1 , 6.1 )
brand names
  1. Vectibix
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2
generic names
  1. PANITUMUMAB
id
a46c4cd4-282a-4920-9372-759f83c286fa
indications and usage exact
  1. 1 INDICATIONS AND USAGE Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1 , 14.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC)* In combination with sotorasib, for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1 ) *Limitations of Use: Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown ( 1 , 2.1 , 5.2 , 12.1 , 14.3 ). Metastatic Colorectal Cancer (mCRC) RAS Wild-Type mCRC Vectibix is indicated for the treatment of adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) metastatic colorectal cancer (mCRC) [see Dosage and Administration (2.1) ] : As first-line therapy in combination with FOLFOX [see Clinical Studies (14.2) ] . As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy [see Clinical Studies (14.1) ] . KRAS G12C -mutated mCRC Vectibix, in combination with sotorasib, is indicated for the treatment of adult patients with KRAS G12C- mutated mCRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy [see Dosage and Administration (2.1) and Clinical Studies (14.4) ] . Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Amgen, Inc
    matched search terms
    1. cancer
    package ndcs
    1. 55513-954-01
    2. 55513-954-21
    3. 55513-956-01
    4. 55513-956-21
    product ndcs
    1. 55513-954
    2. 55513-956
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage ( 1 ) 01/2025 Dosage and Administration ( 2.1 , 2.2 , 2.3 ) 01/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.5 , 5.6 , 5.8 ) 01/2025
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    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.
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    source url
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    spl effective date
    2026-06-23
    spl effective time
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    spl set id
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    spl version
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    substance names
    1. PANITUMUMAB
    uniis
    1. 6A901E312A
    verification flags
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    Drugs@FDA application source records
    1. application number
      BLA125147
      payload
      all indexed label documents
      1. Appl No
        125147
        Application Docs Date
        2006-09-28 00:00:00
        Application Docs ID
        18800
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        125147
        Application Docs Date
        2008-07-14 00:00:00
        Application Docs ID
        18801
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        26
        Submission Type
        SUPPL
      3. Appl No
        125147
        Application Docs Date
        2012-08-20 00:00:00
        Application Docs ID
        18802
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        148
        Submission Type
        SUPPL
      4. Appl No
        125147
        Application Docs Date
        2015-03-12 00:00:00
        Application Docs ID
        18803
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        200
        Submission Type
        SUPPL
      5. Appl No
        125147
        Application Docs Date
        2007-12-03 00:00:00
        Application Docs ID
        39854
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        18
        Submission Type
        SUPPL
      6. Appl No
        125147
        Application Docs Date
        2009-05-07 00:00:00
        Application Docs ID
        39855
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        67
        Submission Type
        SUPPL
      7. Appl No
        125147
        Application Docs Date
        2009-07-21 00:00:00
        Application Docs ID
        39856
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        80
        Submission Type
        SUPPL
      8. Appl No
        125147
        Application Docs Date
        2014-05-28 00:00:00
        Application Docs ID
        39857
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        108
        Submission Type
        SUPPL
      9. Appl No
        125147
        Application Docs Date
        2013-04-01 00:00:00
        Application Docs ID
        39858
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        169
        Submission Type
        SUPPL
      10. Appl No
        125147
        Application Docs Date
        2014-05-28 00:00:00
        Application Docs ID
        39859
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        186
        Submission Type
        SUPPL
      11. Appl No
        125147
        Application Docs Date
        2014-09-03 00:00:00
        Application Docs ID
        39860
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        194
        Submission Type
        SUPPL
      12. Appl No
        125147
        Application Docs Date
        2017-06-30 00:00:00
        Application Docs ID
        48873
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        207
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        125147
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        213
        Submission Status
        AP
        Submission Status Date
        2025-01-16 00:00:00
        Submission Type
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        Submissions Public Notes
      2. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        210
        Submission Status
        AP
        Submission Status Date
        2021-08-25 00:00:00
        Submission Type
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        Submissions Public Notes
      3. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        207
        Submission Status
        AP
        Submission Status Date
        2017-06-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        200
        Submission Status
        AP
        Submission Status Date
        2015-03-11 00:00:00
        Submission Type
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        Submissions Public Notes
      5. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        194
        Submission Status
        AP
        Submission Status Date
        2014-08-30 00:00:00
        Submission Type
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        Submissions Public Notes
      6. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        186
        Submission Status
        AP
        Submission Status Date
        2014-05-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        169
        Submission Status
        AP
        Submission Status Date
        2013-03-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        152
        Submission Status
        AP
        Submission Status Date
        2012-08-17 00:00:00
        Submission Type
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        Submissions Public Notes
      9. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        148
        Submission Status
        AP
        Submission Status Date
        2012-08-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        137
        Submission Status
        AP
        Submission Status Date
        2011-12-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        123
        Submission Status
        AP
        Submission Status Date
        2011-03-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        125147
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        108
        Submission Status
        AP
        Submission Status Date
        2014-05-23 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
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      latest approved submission date
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      latest posted label documents
      1. Appl No
        125147
        Application Docs Date
        2025-01-17 00:00:00
        Application Docs ID
        80860
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
        213
        Submission Type
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      official application record
      Appl No
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      Appl Public Notes
      Appl Type
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      Sponsor Name
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      openfda application present
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      products
      1. Active Ingredient
        PANITUMUMAB
        Appl No
        125147
        Drug Name
        VECTIBIX
        Form
        INJECTABLE; IV (INFUSION)
        Product No
        001
        Reference Drug
        0
        Reference Standard
        Strength
        5ML/100MG
        marketing status
        1. Prescription
      2. Active Ingredient
        PANITUMUMAB
        Appl No
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        Drug Name
        VECTIBIX
        Form
        INJECTABLE; IV (INFUSION)
        Product No
        002
        Reference Drug
        0
        Reference Standard
        Strength
        10ML/200MG
        marketing status
        1. Prescription
      3. Active Ingredient
        PANITUMUMAB
        Appl No
        125147
        Drug Name
        VECTIBIX
        Form
        INJECTABLE; IV (INFUSION)
        Product No
        003
        Reference Drug
        0
        Reference Standard
        Strength
        20ML/400MG
        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. BLA125147
    brand names
    1. Vectibix
    classification reasons
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    exact text
    1 INDICATIONS AND USAGE Vectibix is an epidermal growth factor receptor (EGFR) antagonist indicated for the treatment of: Adult patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test) Metastatic Colorectal Cancer (mCRC)*: In combination with FOLFOX for first-line treatment. ( 1 , 14.2 ) As monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. ( 1 , 14.1 ) KRAS G12C-mutated Metastatic C
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      Metastatic Colorectal Cancer (mCRC)*: In co
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      Metastatic Colorectal Cancer (mCRC)*: In comb
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                                        the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC.
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                                        regimen
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                                        not_inferred
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                                        2185
                                        end exclusive
                                        true
                                        exact text
                                        in combination with sotorasib in KRAS G12C-mutated mCRC
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                                          Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC.
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                                          Source null
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                                          and Clinical Studies (14.4) ] . Limitations of Use : Vectibix is not indicated for the treatment of patients with RAS -mutant mCRC unless used in combination with sotorasib in KRAS G12C-mutated mCRC. Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] .
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                                                Vectibix is not indicated for the treatment of patients with mCRC for whom RAS mutation status is unknown [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Clinical Pharmacology (12.1) and Clinical Studies (14.3) ] .
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                                                source url
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                                                approval pathway
                                                Source null
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                                                Source null
                                                line
                                                Source null
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                                                Source null
                                                regimen
                                                Source null
                                                tumor histology
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                                                Preserved source evidence · Not medical advice