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LABELS · ca8057b2-9aec-43bc-8525-cf8091433c71

ALYMSYS

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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
2026-03-23
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Alymsys 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: Alymsys 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 paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6) 1.1 Metastatic Colorectal Cancer Alymsys, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Alymsys, 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: Alymsys 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 Alymsys, 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 Alymsys is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Alymsys, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer Alymsys, 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 Alymsys, 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.
Full extracted label fields
application numbers
  1. BLA761231
boxed warning exact
    brand names
    1. ALYMSYS
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b4040a2-a5c5-4ff0-ab45-935d7e49cf78
    generic names
    1. BEVACIZUMAB-MALY
    id
    ca8057b2-9aec-43bc-8525-cf8091433c71
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Alymsys 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: Alymsys 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 paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens (1.6) 1.1 Metastatic Colorectal Cancer Alymsys, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mCRC). Alymsys, 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: Alymsys 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 Alymsys, 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 Alymsys is indicated for the treatment of recurrent glioblastoma (GBM) in adults. 1.4 Metastatic Renal Cell Carcinoma Alymsys, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mRCC). 1.5 Persistent, Recurrent, or Metastatic Cervical Cancer Alymsys, 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 Alymsys, 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.
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Amneal Pharmaceuticals LLC
      matched search terms
      1. cancer
      2. carcinoma
      3. glioblastoma
      package ndcs
      1. 70121-1754-7
      2. 70121-1754-1
      3. 70121-1755-7
      4. 70121-1755-1
      product ndcs
      1. 70121-1754
      2. 70121-1755
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
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        routes
        1. INTRAVENOUS
        rxcuis
        1. 2599043
        2. 2599049
        3. 2599051
        4. 2599052
        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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        limit
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        sha256
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        url
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        source url
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        spl effective date
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        spl effective time
        20260323
        spl set id
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        spl version
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        substance names
        1. BEVACIZUMAB
        uniis
        1. 2S9ZZM9Q9V
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        Drugs@FDA application source records
        1. application number
          BLA761231
          payload
          all indexed label documents
          1. Appl No
            761231
            Application Docs Date
            2022-04-13 00:00:00
            Application Docs ID
            70759
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          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
            2022-04-13 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          application number
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          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
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          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
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            Submission Type
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          official application record
          Appl No
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          Appl Public Notes
          Appl Type
          BLA
          Sponsor Name
          AMNEAL PHARMS LLC
          openfda application present
          true
          products
          1. Active Ingredient
            BEVACIZUMAB-MALY
            Appl No
            761231
            Drug Name
            ALYMSYS
            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-MALY
            Appl No
            761231
            Drug Name
            ALYMSYS
            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. BLA761231
        brand names
        1. ALYMSYS
        classification reasons
        1. explicit_positive_indication_predicate
        2. tumor_or_malignant_hematology_words_in_positive_statement
        clinical review status
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        content role
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        true
        exact text
        1 INDICATIONS AND USAGE Alymsys 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
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        generic names
        1. BEVACIZUMAB-MALY
        id
        ind-span-7df66e069437f740f605
        label id
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        is a vascular endothelial growth factor inhibitor indicated
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        qualifier mentions
        1. context exact
          ial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemoth
          kind
          biomarker
          polarity
          not_inferred
          span
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          Metastatic colorectal cancer
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          Metastatic colorectal cancer
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        4. context exact
          dicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
          kind
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          true
          exact text
          in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment
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        regulatory links
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            non–small cell lung cancer (NSCLC)
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          1 INDICATIONS AND USAGE Alymsys 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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          source url
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          spl effective date
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          spl set id
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          spl version
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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
          tumor_directed_candidate
          Passage 2 · positive indication candidate
          application numbers
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          brand names
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          classification reasons
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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: Alymsys 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 co
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                                        Preserved source evidence · Not medical advice