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STATUS · fda-aa-b5d3c853ddc4e9301e35

Tecartus (brexucabtagene autoleucel)

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 relapsed or refractory mantle cell lymphoma (MCL).

Source status category
ongoing
Event date
2020-07-24
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2020-07-24
accelerated approval date source text
7/24/2020
brand name hint
Tecartus
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Tecartus (brexucabtagene autoleucel)
generic name hint
brexucabtagene autoleucel
id
fda-aa-b5d3c853ddc4e9301e35
indication exact
Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
original projected completion source text
10/31/2025
post marketing requirement exact
1: Complete additional follow-up of all 68 subjects treated with brexucabtagene autoleucel in ZUMA-2 Cohort 1 to a minimum of 18 months from the time of first response. Data will continue to be collected according to the ZUMA-2 protocol’s established schedule of assessments. 2: Conduct a study of brexucabtagene autoleucel treatment of subjects with relapsed or refractory mantle cell lymphoma who have not been exposed to a Bruton tyrosine kinase (BTK) inhibitor. A cohort of subjects naïve to BTK inhibitor therapy will be added to the ongoing ZUMA-2 study to fulfill this requirement. Eighty-six subjects will be enrolled. The primary efficacy endpoint will be objective response rate with a supportive efficacy endpoint of duration of response based on a minimum follow-up of 18 months after first objective disease response.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Tecartus (brexucabtagene autoleucel)
      1. links
          text
          Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
        1. links
            text
            7/24/2020
          1. links
              text
              1: Complete additional follow-up of all 68 subjects treated with brexucabtagene autoleucel in ZUMA-2 Cohort 1 to a minimum of 18 months from the time of first response. Data will continue to be collected according to the ZUMA-2 protocol’s established schedule of assessments. 2: Conduct a study of brexucabtagene autoleucel treatment of subjects with relapsed or refractory mantle cell lymphoma who have not been exposed to a Bruton tyrosine kinase (BTK) inhibitor. A cohort of subjects naïve to BTK inhibitor therapy will be added to the ongoing ZUMA-2 study to fulfill this requirement. Eighty-six subjects will be enrolled. The primary efficacy endpoint will be objective response rate with a supportive efficacy endpoint of duration of response based on a minimum follow-up of 18 months after first objective disease response.
            1. links
                text
                10/31/2025
              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
              50
              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
              2020-07-24
              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
                Tecartus (brexucabtagene autoleucel)
                fda status record id
                fda-aa-b5d3c853ddc4e9301e35
                indication exact
                Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-16b5887b6004e209c44b
                2. ind-span-be9f1b9be895c03a94fa
                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-644222e09dd16ab4ea1402f2
                  span id
                  ind-span-16b5887b6004e209c44b
                  status id
                  fda-aa-b5d3c853ddc4e9301e35
                  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
                  207
                  end exclusive
                  true
                  exact text
                  1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
                  label id
                  17c4a716-a22e-486d-b633-4be6c2453266
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  fe397737acfb15e614c22a84ff6b93764b638fbc4c9b6407c0f306813a200e93
                  start
                  0
                  fda indication exact
                  Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
                  fda source row index
                  50
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-b5d3c853ddc4e9301e35
                  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
                  2020-07-24
                  supporting anchor spans
                  1. package id
                    fda-label-library-8184721b7b3bb86692f8276c
                    correspondence id
                    correspondence-af2aff0afdd0ec5cefd8b9f2
                    span id
                    ind-span-be9f1b9be895c03a94fa
                    status id
                    fda-aa-b5d3c853ddc4e9301e35
                    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
                    442
                    end exclusive
                    true
                    exact text
                    1.1 Mantle Cell Lymphoma TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
                    label id
                    17c4a716-a22e-486d-b633-4be6c2453266
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    fe397737acfb15e614c22a84ff6b93764b638fbc4c9b6407c0f306813a200e93
                    start
                    304
                    fda indication exact
                    Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
                    fda source row index
                    50
                    fda source sha256
                    8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                    fda status record id
                    fda-aa-b5d3c853ddc4e9301e35
                    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
                    2020-07-24
                    supporting anchor spans

                    Preserved source evidence · Not medical advice