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LABELS · ea079b8e-24b7-4e03-8340-8078f30f6d98

MVASI

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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
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) Recurrent glioblastoma in adults. ( 1.3 ) Metastatic renal cell carcinoma in combination with interferon-alfa. ( 1.4 ) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. ( 1.5 ) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection ( 1.6 ) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens ( 1.6 ) in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease ( 1.6 ) 1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer MVASI, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma MVASI is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma MVASI, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer MVASI, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MVASI, in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. MVASI, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. MVASI, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by MVASI as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Full extracted label fields
application numbers
  1. BLA761028
boxed warning exact
    brand names
    1. MVASI
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a562b4e-67ce-4bab-852c-d9ee71e55fb8
    generic names
    1. BEVACIZUMAB-AWWB
    id
    ea079b8e-24b7-4e03-8340-8078f30f6d98
    indications and usage exact
    1. 1 INDICATIONS AND USAGE MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment. ( 1.2 ) Recurrent glioblastoma in adults. ( 1.3 ) Metastatic renal cell carcinoma in combination with interferon-alfa. ( 1.4 ) Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan. ( 1.5 ) Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, for stage III or IV disease following initial surgical resection ( 1.6 ) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens ( 1.6 ) in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease ( 1.6 ) 1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer MVASI, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma MVASI is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma MVASI, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer MVASI, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MVASI, in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection. MVASI, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. MVASI, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by MVASI as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amgen, Inc
      matched search terms
      1. cancer
      2. carcinoma
      3. glioblastoma
      package ndcs
      1. 55513-206-01
      2. 55513-206-21
      3. 55513-207-01
      4. 55513-207-21
      product ndcs
      1. 55513-206
      2. 55513-207
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        routes
        1. INTRAVENOUS
        rxcuis
        1. 2046140
        2. 2046145
        3. 2046148
        4. 2046149
        source batch
        file
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        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
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        url
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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. BEVACIZUMAB
        uniis
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        verification flags
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        Drugs@FDA application source records
        1. application number
          BLA761028
          payload
          all indexed label documents
          1. Appl No
            761028
            Application Docs Date
            2017-09-14 00:00:00
            Application Docs ID
            49729
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
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          2. Appl No
            761028
            Application Docs Date
            2019-06-27 00:00:00
            Application Docs ID
            59180
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            4
            Submission Type
            SUPPL
          3. Appl No
            761028
            Application Docs Date
            2021-04-20 00:00:00
            Application Docs ID
            67125
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            6
            Submission Type
            SUPPL
          4. Appl No
            761028
            Application Docs Date
            2021-11-16 00:00:00
            Application Docs ID
            69325
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            8
            Submission Type
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          5. Appl No
            761028
            Application Docs Date
            2023-02-21 00:00:00
            Application Docs ID
            73576
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            11
            Submission Type
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          all submission records
          1. Appl No
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            Review Priority
            STANDARD
            Submission Class Code ID
            15
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2017-09-14 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            761028
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            4
            Submission Status
            AP
            Submission Status Date
            2019-06-24 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          3. Appl No
            761028
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2021-04-19 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          4. Appl No
            761028
            Review Priority
            STANDARD
            Submission Class Code ID
            2
            Submission No
            8
            Submission Status
            AP
            Submission Status Date
            2021-11-15 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          5. Appl No
            761028
            Review Priority
            STANDARD
            Submission Class Code ID
            1
            Submission No
            11
            Submission Status
            AP
            Submission Status Date
            2023-02-17 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          BLA761028
          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
          2023-02-17
          latest label selection rule
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          latest posted label documents
          1. Appl No
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            Application Docs Date
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            Application Docs ID
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            Application Docs Title
            0
            Application Docs Type ID
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            Submission No
            11
            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          AMGEN INC
          openfda application present
          true
          products
          1. Active Ingredient
            BEVACIZUMAB-AWWB
            Appl No
            761028
            Drug Name
            MVASI
            Form
            INJECTABLE; INJECTION
            Product No
            001
            Reference Drug
            0
            Reference Standard
            0
            Strength
            100MG/4ML (25MG/ML)
            marketing status
            1. Prescription
          2. Active Ingredient
            BEVACIZUMAB-AWWB
            Appl No
            761028
            Drug Name
            MVASI
            Form
            INJECTABLE; INJECTION
            Product No
            002
            Reference Drug
            0
            Reference Standard
            0
            Strength
            400MG/16ML (25MG/ML)
            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. BLA761028
        brand names
        1. MVASI
        classification reasons
        1. explicit_positive_indication_predicate
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        exact text
        1 INDICATIONS AND USAGE MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on
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        is a vascular endothelial growth factor inhibitor indicated
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        1. context exact
          ial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemoth
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          Metastatic colorectal cancer
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          in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
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        regulatory links
          schema version
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          source defined aliases
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            NSCLC
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            non-small cell lung cancer (NSCLC)
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          1 INDICATIONS AND USAGE MVASI is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
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          spl effective date
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          structured fields status
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
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          Source null
          tumor histology
          Source null
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          tumor_directed_candidate
          Passage 2 · positive indication candidate
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          endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. ( 1.1 ) Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen. ( 1.1 ) Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer. ( 1.1 ) Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in
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                            rior chemotherapy regimens ( 1.6 ) in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by MVASI as a single agent, for platinum-sensitive recurrent disease ( 1.6 ) 1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a f
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                              1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemoth
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                              Metastatic Colorectal Cancer MVASI
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                              1811
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                              metastatic colorectal cancer (mCRC)
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                              1639
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                              exact text
                              Metastatic Colorectal Cancer MVASI
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                              metastatic colorectal cancer (mCRC)
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                              rouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
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                              second-line treatment of patients with metastatic colorectal cancer (mCRC)
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                              in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC)
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                              1.1 Metastatic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC).
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                              spl effective date
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                              spl version
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                              Source null
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                              Source null
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                              Source null
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                              Source null
                              line
                              Source null
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                              Source null
                              regimen
                              Source null
                              tumor histology
                              Source null
                              use intent
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                              application numbers
                              1. BLA761028
                              brand names
                              1. MVASI
                              classification reasons
                              1. explicit_positive_indication_predicate
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                              clinical review status
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                              true
                              exact text
                              ic Colorectal Cancer MVASI, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC). MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer MVASI, in combination with ca
                              label id
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                              qualifier mentions
                              1. context exact
                                midine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
                                kind
                                prior_therapy_or_line
                                polarity
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                                second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen
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                                MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regime
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                                in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have prog
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                                MVASI, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen.
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                                source url
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                                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
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                                application numbers
                                1. BLA761028
                                brand names
                                1. MVASI
                                classification reasons
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                                clinical review status
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                                content role
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                                true
                                exact text
                                tecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer MVASI, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced
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                                Source null
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                                  Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ].
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                                  adjuvant treatment of colon cancer [see Cli
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                                  source defined aliases
                                  1. abbreviation
                                    NSCLC
                                    definition exact
                                    non-small cell lung cancer
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                                    non-small cell lung cancer (NSCLC)
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                                  Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ].
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                                  structured fields status
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                                  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
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                                  application numbers
                                  1. BLA761028
                                  brand names
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                                  classification reasons
                                  1. explicit_positive_indication_predicate
                                  2. tumor_or_malignant_hematology_words_in_positive_statement
                                  clinical review status
                                  pending
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                                  2650
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                                  true
                                  exact text
                                  ith mCRC who have progressed on a first-line bevacizumab product-containing regimen. Limitations of Use : MVASI is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ]. 1.2 First-Line Non-Squamous Non-Small Cell Lung Cancer MVASI, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma MVASI is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma MVASI, in combination with interferon-alfa, is indicated
                                  label id
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                                  1977
                                  current approval status
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                                  duplicate text group
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                                  true
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                                    patients with unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC).
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                                    biomarker
                                    polarity
                                    not_inferred
                                    span
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                                    unresectable
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                                      source url
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                                      qualifier mentions
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                                        1.4 Metastatic Renal Cell Carcinoma MVASI, in combination with interferon-alfa, is indicated for the
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                                        source url
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                                        spl effective date
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                                        spl set id
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                                        Source null
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                                        Source null
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                                        Source null
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                                        Source null
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                                        Source null
                                        line
                                        Source null
                                        prior therapy
                                        Source null
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                                        Source null
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                                        Source null
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                                        application numbers
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                                        brand names
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                                        nt of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma MVASI, in combination with interferon-alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer MVASI, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. 1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MVASI, in combination with carboplatin and paclitaxel, followed by MVASI as a single agent, is indicated for the treatment of pati
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                                          biomarker
                                          polarity
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                                                indications_and_usage_exact
                                                source text sha256
                                                988d998b4249dbcf291f76db6ce10acc2c95a7cd3bbf8a29a009675eac1af409
                                                start
                                                3564
                                                source url
                                                https://api.fda.gov/drug/label.json?search=id%3A%22ea079b8e-24b7-4e03-8340-8078f30f6d98%22
                                                spl effective date
                                                2026-06-23
                                                spl set id
                                                0a562b4e-67ce-4bab-852c-d9ee71e55fb8
                                                spl version
                                                23
                                                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

                                                Preserved source evidence · Not medical advice