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LABELS · 2644fd0e-5b94-9120-bdb1-e275d982b249

JOBEVNE

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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
2026-03-11
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Jobevne 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 : Jobevne 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: o in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent, for stage III or IV disease following initial surgical resection ( 1.6 ) o 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 ) o in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease ( 1.6 ) 1.1 Metastatic Colorectal Cancer Jobevne, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Jobevne, 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 Jobevne 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 Jobevne, 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 Jobevne is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Jobevne, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer Jobevne, 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 Jobevne, in combination with carboplatin and paclitaxel, followed by Jobevne 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. Jobevne, 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. Jobevne, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Jobevne 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. BLA761175
boxed warning exact
    brand names
    1. JOBEVNE
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=70ab1de6-fb68-aee4-a6cb-f9a0f146687f
    generic names
    1. BEVACIZUMAB-NWGD
    id
    2644fd0e-5b94-9120-bdb1-e275d982b249
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Jobevne 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 : Jobevne 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: o in combination with carboplatin and paclitaxel, followed by Jobevne as a single agent, for stage III or IV disease following initial surgical resection ( 1.6 ) o 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 ) o in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Jobevne as a single agent, for platinum-sensitive recurrent disease ( 1.6 ) 1.1 Metastatic Colorectal Cancer Jobevne, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Jobevne, 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 Jobevne 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 Jobevne, 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 Jobevne is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Jobevne, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer Jobevne, 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 Jobevne, in combination with carboplatin and paclitaxel, followed by Jobevne 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. Jobevne, 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. Jobevne, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Jobevne 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
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      1. Biocon Biologics Inc.
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        openfda application present
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        products
        1. Active Ingredient
          BEVACIZUMAB-NWGD
          Appl No
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          Drug Name
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          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
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          Reference Standard
          0
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        2. Active Ingredient
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          Appl No
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          Drug Name
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          Form
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          Product No
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          Reference Drug
          2
          Reference Standard
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          Strength
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          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
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      1 INDICATIONS AND USAGE Jobevne 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 fluorop
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          1 INDICATIONS AND USAGE Jobevne is a vascular endothelial growth factor inhibitor indicated for the treatment of:
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          1 INDICATIONS AND USAGE Jobevne 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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            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
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                                                    1.1 Metastatic Colorectal Cancer Jobevne, 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 Jobevne, 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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                                                    c Colorectal Cancer Jobevne, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Jobevne, 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 Jobevne 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 Jobevne, in combination with
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                                                    1949
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                                                    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
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                                                    2. context exact
                                                      Jobevne, 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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                                                      in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mCRC who have progr
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                                                      Jobevne, 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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                                                      otecan-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 Jobevne 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 Jobevne, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanc
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                                                        Limitations of Use Jobevne is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ].
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                                                        Limitations of Use Jobevne is not indicated for adjuvant treatment of colon cancer [see Clinical Studies (14.2) ].
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                                                          patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
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                                                        4. context exact
                                                          treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC).
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                                                          2408
                                                        5. context exact
                                                          1.2 First-Line Non-Squamous Non–Small Cell Lung Cancer Jobevne, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squ
                                                          kind
                                                          prior_therapy_or_line
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                                                          not_inferred
                                                          span
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                                                          1.2 First-Line Non-Squamous Non–Small Cell Lung Cancer Jobevne, 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).
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                                                          on 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 Jobevne is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Jobevne, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Ce
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                                                            locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (NSCLC). 1.3 Recurrent Glioblastoma Jobevne is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Jobevne, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer Jobevne, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent,
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                                                                  1.6 Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Jobevne, in combination with carboplatin and paclitaxel, followed by Jobevne 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.
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                                                                      in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Jobevne as a single agent, is indicated for the treatment of patients with platinu
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                                                                      source defined aliases
                                                                      1. abbreviation
                                                                        NSCLC
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                                                                        non–small cell lung cancer
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                                                                        non–small cell lung cancer (NSCLC)
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                                                                      exact text
                                                                      Jobevne, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Jobevne as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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                                                                      2644fd0e-5b94-9120-bdb1-e275d982b249
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                                                                      3606
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                                                                      https://api.fda.gov/drug/label.json?search=id%3A%222644fd0e-5b94-9120-bdb1-e275d982b249%22
                                                                      spl effective date
                                                                      2026-03-11
                                                                      spl set id
                                                                      70ab1de6-fb68-aee4-a6cb-f9a0f146687f
                                                                      spl version
                                                                      5
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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
                                                                      tumor_directed_candidate

                                                                      Preserved source evidence · Not medical advice