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STATUS · fda-aa-d4ad691142ed2bc68c9b

Zynyz (retifanlimab-dlwr)

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

Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)

Source status category
verified clinical benefit
Event date
2025-12-17
Meaning of this date
FDA table traditional approval date
accelerated approval date
2023-03-22
accelerated approval date source text
3/22/2023
brand name hint
Zynyz
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Zynyz (retifanlimab-dlwr)
generic name hint
retifanlimab-dlwr
id
fda-aa-d4ad691142ed2bc68c9b
indication exact
Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
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-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel
source cells exact
  1. links
      text
      Zynyz (retifanlimab-dlwr)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-metastatic-or-recurrent-locally-advanced-merkel
      text
      Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
    2. links
        text
        3/22/2023
      1. links
          text
          12/17/2025
        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
        7
        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
        2025-12-17
        status event date meaning
        FDA table traditional approval date
        traditional approval date
        2025-12-17
        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
          Zynyz (retifanlimab-dlwr)
          fda status record id
          fda-aa-d4ad691142ed2bc68c9b
          indication exact
          Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
          match status
          source_correspondence_found_clinical_review_pending
          matched candidate ids
          1. ind-span-5b35518245e3f5dc1354
          2. ind-span-3935c7a2f450ae97e24d
          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-8a55dbc64fd63259edb4a3ff
            span id
            ind-span-5b35518245e3f5dc1354
            status id
            fda-aa-d4ad691142ed2bc68c9b
            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
            665
            end exclusive
            true
            exact text
            ( 1.1 ) Merkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
            label id
            91ad9008-46bd-4619-946f-75174fceaf56
            offset unit
            unicode_code_points
            source array index
            0
            source field
            indications_and_usage_exact
            source text sha256
            82ccd7ac4103b01fb059c65858ed18f55651bf62fe9bd430380d81e667522502
            start
            519
            fda indication exact
            Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
            fda source row index
            7
            fda source sha256
            91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
            fda status record id
            fda-aa-d4ad691142ed2bc68c9b
            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
            2025-12-17
            supporting anchor spans
            1. package id
              fda-label-library-8184721b7b3bb86692f8276c
              correspondence id
              correspondence-d9594aa078f62ef13d812247
              span id
              ind-span-3935c7a2f450ae97e24d
              status id
              fda-aa-d4ad691142ed2bc68c9b
              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
              1280
              end exclusive
              true
              exact text
              1.2 Merkel Cell Carcinoma ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
              label id
              91ad9008-46bd-4619-946f-75174fceaf56
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              82ccd7ac4103b01fb059c65858ed18f55651bf62fe9bd430380d81e667522502
              start
              1125
              fda indication exact
              Adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
              fda source row index
              7
              fda source sha256
              91f921503728c2afb0ec500d9c6034553e0b81d5af260a20c5478686c1127a7e
              fda status record id
              fda-aa-d4ad691142ed2bc68c9b
              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
              2025-12-17
              supporting anchor spans

              Preserved source evidence · Not medical advice