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STATUS · fda-aa-cce79c5ca7c6bc87f74f

Kymriah (tisagenlecleucel)

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

Source status category
ongoing
Event date
2022-05-27
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2022-05-27
accelerated approval date source text
5/27/2022
brand name hint
Kymriah
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Kymriah (tisagenlecleucel)
generic name hint
tisagenlecleucel
id
fda-aa-cce79c5ca7c6bc87f74f
indication exact
Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
original projected completion source text
9/30/2028
post marketing requirement exact
Conduct a randomized phase 3 trial in adult patients with r/r FL. Patients will be randomized to tisagenlecleucel or an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS with secondary endpoints that include OS and ORR.
record type
fda_accelerated_approval_status_row
related fda urls
    source cells exact
    1. links
        text
        Kymriah (tisagenlecleucel)
      1. links
          text
          Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
        1. links
            text
            5/27/2022
          1. links
              text
              Conduct a randomized phase 3 trial in adult patients with r/r FL. Patients will be randomized to tisagenlecleucel or an investigator’s choice of regimens consistent with the standard of care. The primary endpoint will be PFS with secondary endpoints that include OS and ORR.
            1. links
                text
                9/30/2028
              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
              40
              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
              2022-05-27
              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
                Kymriah (tisagenlecleucel)
                fda status record id
                fda-aa-cce79c5ca7c6bc87f74f
                indication exact
                Treatment of adult patients with relapsed or refractory (r/r) 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-8523496d7feebadaa0d9
                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-86001f19f74e7a1b4b0b25f3
                  span id
                  ind-span-8523496d7feebadaa0d9
                  status id
                  fda-aa-cce79c5ca7c6bc87f74f
                  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
                  1981
                  end exclusive
                  true
                  exact text
                  1.3 Adult Relapsed or Refractory Follicular Lymphoma KYMRIAH is indicated for treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.
                  label id
                  381f1ba3-f115-424f-9890-75eb06ab6666
                  offset unit
                  unicode_code_points
                  source array index
                  0
                  source field
                  indications_and_usage_exact
                  source text sha256
                  a9debacdb256ddbeb9b9206a786252d6198d6084a56e17e3eb1aad2bdd76b7de
                  start
                  1772
                  fda indication exact
                  Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
                  fda source row index
                  40
                  fda source sha256
                  8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                  fda status record id
                  fda-aa-cce79c5ca7c6bc87f74f
                  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
                  2022-05-27
                  supporting anchor spans

                  Preserved source evidence · Not medical advice