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STATUS · fda-aa-362e4da2080143274786

Tivdak (tisotumab vedotin-tftv)

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 adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy

Source status category
verified clinical benefit
Event date
2024-04-29
Meaning of this date
FDA table traditional approval date
accelerated approval date
2021-09-20
accelerated approval date source text
9/20/2021
brand name hint
Tivdak
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Tivdak (tisotumab vedotin-tftv)
generic name hint
tisotumab vedotin-tftv
id
fda-aa-362e4da2080143274786
indication exact
Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
original projected completion source text
Source null
post marketing requirement exact
Source null
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
source cells exact
  1. links
      text
      Tivdak (tisotumab vedotin-tftv)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
      text
      Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
    2. links
        text
        9/20/2021
      1. links
          text
          4/29/2024
        source provenance
        bytes
        74315
        file
        /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
        http status
        200
        retrieved at
        2026-09-09T23:35:16.058704+00:00
        sha256
        91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
        source page date Modified text
        Wed, 07/15/2026 - 00:00
        source page date Published text
        Wed, 07/15/2026 - 07:11
        source row index
        22
        source table headers
        1. Drug Name
        2. Accelerated Approval (AA) Indication
        3. Accelerated Approval Date
        4. Traditional Approval Date
        source table index
        0
        source url
        https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
        status applies to
        This exact indication and regimen, not every use of this drug
        status category
        verified_clinical_benefit
        status event date
        2024-04-29
        status event date meaning
        FDA table traditional approval date
        traditional approval date
        2024-04-29
        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
          Tivdak (tisotumab vedotin-tftv)
          fda status record id
          fda-aa-362e4da2080143274786
          indication exact
          Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
          match status
          source_correspondence_found_clinical_review_pending
          matched candidate ids
          1. ind-span-19e899768cde2b8bcd21
          2. ind-span-4b048ef91cfd4018624c
          source provenance
          bytes
          74315
          file
          /private/tmp/cancer-full-research/indications/raw/accelerated-verified.html
          http status
          200
          retrieved at
          2026-09-09T23:35:16.058704+00:00
          sha256
          91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
          source page date Modified text
          Wed, 07/15/2026 - 00:00
          source page date Published text
          Wed, 07/15/2026 - 07:11
          status category
          verified_clinical_benefit
          unmatched meaning
          Source null
          links
          1. package id
            fda-label-library-8184721b7b3bb86692f8276c
            correspondence id
            correspondence-4851a0088c10ad92de11c710
            span id
            ind-span-19e899768cde2b8bcd21
            status id
            fda-aa-362e4da2080143274786
            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
            177
            end exclusive
            true
            exact text
            1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
            label id
            62959a22-02f7-463c-80bb-3c5e621b1f58
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            5ccd8f1e7f0fefbd7bd40e462069f73aac2082b9988983fa65b1a5d26b2f89f6
            start
            0
            fda indication exact
            Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
            fda source row index
            22
            fda source sha256
            91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
            fda status record id
            fda-aa-362e4da2080143274786
            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
            verified_clinical_benefit
            status event date
            2024-04-29
            supporting anchor spans
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-8f7ca8c19d26aad1be251a49
              span id
              ind-span-4b048ef91cfd4018624c
              status id
              fda-aa-362e4da2080143274786
              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
              399
              end exclusive
              true
              exact text
              TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
              label id
              62959a22-02f7-463c-80bb-3c5e621b1f58
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              5ccd8f1e7f0fefbd7bd40e462069f73aac2082b9988983fa65b1a5d26b2f89f6
              start
              178
              fda indication exact
              Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
              fda source row index
              22
              fda source sha256
              91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
              fda status record id
              fda-aa-362e4da2080143274786
              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
              verified_clinical_benefit
              status event date
              2024-04-29
              supporting anchor spans

              Preserved source evidence · Not medical advice