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STATUS · fda-aa-fb71fba1f2fb5f1e6b1a

Bizengri (zenocutuzumab-zbco)

Open original source → · Download preserved record

This status concerns only the indication wording below. It must not be applied to other uses of the same drug. It is not reconciled against the current label.

Exact indication

Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

Source status category
ongoing
Event date
2024-12-04
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2024-12-04
accelerated approval date source text
12/4/2024
brand name hint
Bizengri
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Bizengri (zenocutuzumab-zbco)
generic name hint
zenocutuzumab-zbco
id
fda-aa-fb71fba1f2fb5f1e6b1a
indication exact
Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
original projected completion source text
8/31/2026
post marketing requirement exact
4727-2: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 50 evaluable adult patients with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy (or who are not eligible for standard of care therapy). To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic
source cells exact
  1. links
      text
      Bizengri (zenocutuzumab-zbco)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zenocutuzumab-zbco-non-small-cell-lung-cancer-and-pancreatic
      text
      Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
    2. links
        text
        12/4/2024
      1. links
          text
          4727-2: Complete a clinical trial intended to verify and describe the clinical benefit of zenocutuzumab 750 mg intravenously every two weeks in at least 50 evaluable adult patients with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy (or who are not eligible for standard of care therapy). To characterize response rate and duration, patients will be followed for at least 12 months from the onset of response.
        1. links
            text
            8/31/2026
          source provenance
          bytes
          102185
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
          http status
          200
          retrieved at
          2026-09-09T23:35:15.160724+00:00
          sha256
          8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
          source page date Modified text
          Wed, 09/09/2026 - 00:00
          source page date Published text
          Wed, 09/09/2026 - 12:45
          source row index
          16
          source table headers
          1. Drug Name
          2. Accelerated Approval (AA) Indication
          3. AA Date
          4. AA Post-Marketing Requirement
          5. Original Projected Completion 1
          source table index
          0
          source url
          https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
          status applies to
          This exact indication and regimen, not every use of this drug
          status category
          ongoing
          status event date
          2024-12-04
          status event date meaning
          Original accelerated approval date; ongoing status observed at source retrieval
          traditional approval date
          Source null
          verification flags
            verification status
            official_fda_status_table_extracted_indication_matching_not_clinically_reviewed
            withdrawal date
            Source null
            Source correspondence records
            matching
            drug name exact
            Bizengri (zenocutuzumab-zbco)
            fda status record id
            fda-aa-fb71fba1f2fb5f1e6b1a
            indication exact
            Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-0adc6738aed4e1ab44e9
            2. ind-span-09c3498613036997b6bc
            source provenance
            bytes
            102185
            file
            /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
            http status
            200
            retrieved at
            2026-09-09T23:35:15.160724+00:00
            sha256
            8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
            source page date Modified text
            Wed, 09/09/2026 - 00:00
            source page date Published text
            Wed, 09/09/2026 - 12:45
            status category
            ongoing
            unmatched meaning
            Source null
            links
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-4a4a26c3c555d9e640791982
              span id
              ind-span-0adc6738aed4e1ab44e9
              status id
              fda-aa-fb71fba1f2fb5f1e6b1a
              match method
              whole_indication_literal_normalized_substring
              scope relationship
              whole_fda_indication_text_present
              matching review status
              source_comparison_only_clinical_review_pending
              payload
              candidate source span
              end
              1854
              end exclusive
              true
              exact text
              1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
              label id
              777005ee-d019-4976-abb4-b998cf68e05f
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              c916c6a26045e04b891dbaa61246b08ab95a9d3266223c28b0ef36ea1d092c8d
              start
              1544
              fda indication exact
              Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
              fda source row index
              16
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-fb71fba1f2fb5f1e6b1a
              interpretation
              Source wording correspondence to a dated FDA status row; current approval not certified
              match method
              whole_indication_literal_normalized_substring
              matching review status
              source_comparison_only_clinical_review_pending
              scope relationship
              whole_fda_indication_text_present
              status category
              ongoing
              status event date
              2024-12-04
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-bfa7b3b8ce304bb660fc51ea
                span id
                ind-span-09c3498613036997b6bc
                status id
                fda-aa-fb71fba1f2fb5f1e6b1a
                match method
                whole_indication_literal_normalized_substring
                scope relationship
                whole_fda_indication_text_present
                matching review status
                source_comparison_only_clinical_review_pending
                payload
                candidate source span
                end
                1672
                end exclusive
                true
                exact text
                1.2 Advanced Unresectable or Metastatic NRG1 Fusion-Positive Pancreatic Adenocarcinoma BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 ( NRG1 ) gene fusion with disease progression on or after prior systemic therapy.
                label id
                0ba12e0b-78b7-4ef0-b8fd-5127f0b16581
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                0166e9748015139a1b5dcff950e44777862cb4d20cbe6bd962768c129a4d41dc
                start
                1362
                fda indication exact
                Treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
                fda source row index
                16
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
                fda-aa-fb71fba1f2fb5f1e6b1a
                interpretation
                Source wording correspondence to a dated FDA status row; current approval not certified
                match method
                whole_indication_literal_normalized_substring
                matching review status
                source_comparison_only_clinical_review_pending
                scope relationship
                whole_fda_indication_text_present
                status category
                ongoing
                status event date
                2024-12-04
                supporting anchor spans

                Preserved source evidence · Not medical advice