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STATUS · fda-aa-ca8a77a407a7aeda226a

Yescarta (axicabtagene ciloleucel)

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 follicular lymphoma (FL) after two or more lines of systemic therapy

Source status category
ongoing
Event date
2021-03-05
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2021-03-05
accelerated approval date source text
3/5/2021
brand name hint
Yescarta
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Yescarta (axicabtagene ciloleucel)
generic name hint
axicabtagene ciloleucel
id
fda-aa-ca8a77a407a7aeda226a
indication exact
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
original projected completion source text
9/30/2027
post marketing requirement exact
1: A randomized phase 3 trial of axicabtagene ciloleucel in patients with relapsed or refractory FL. Patients will be randomized to axicabtagene ciloleucel or to an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS, with secondary endpoints that include ORR and OS.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Yescarta (axicabtagene ciloleucel)
      1. links
          text
          Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
        1. links
            text
            3/5/2021
          1. links
              text
              1: A randomized phase 3 trial of axicabtagene ciloleucel in patients with relapsed or refractory FL. Patients will be randomized to axicabtagene ciloleucel or to an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS, with secondary endpoints that include ORR and OS.
            1. links
                text
                9/30/2027
              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
              47
              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
              2021-03-05
              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
                Yescarta (axicabtagene ciloleucel)
                fda status record id
                fda-aa-ca8a77a407a7aeda226a
                indication exact
                Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
                match status
                source_correspondence_found_clinical_review_pending
                matched candidate ids
                1. ind-span-1e74bb15380f887db122
                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-869c4df31a068f45470d0897
                  span id
                  ind-span-1e74bb15380f887db122
                  status id
                  fda-aa-ca8a77a407a7aeda226a
                  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
                  1659
                  end exclusive
                  true
                  exact text
                  1.2 Follicular Lymphoma YESCARTA is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
                  label id
                  23cad324-9e01-4dba-8152-354dadb7b1e5
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  914941d43de954118914bfbfc4e3e755dcaf75500e65b6a2e72d7ad7e1f5cd0f
                  start
                  1480
                  fda indication exact
                  Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy
                  fda source row index
                  47
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-ca8a77a407a7aeda226a
                  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
                  2021-03-05
                  supporting anchor spans

                  Preserved source evidence · Not medical advice