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STATUS · fda-aa-54f8004f5a784e287b01

Epkinly (epcoritamab-bysp)

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 relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

Source status category
ongoing
Event date
2023-05-19
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2023-05-19
accelerated approval date source text
5/19/2023
brand name hint
Epkinly
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Epkinly (epcoritamab-bysp)
generic name hint
epcoritamab-bysp
id
fda-aa-54f8004f5a784e287b01
indication exact
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
original projected completion source text
6/30/2025
post marketing requirement exact
4435-1: Complete a randomized clinical trial in patients with relapsed or refractory large B-cell lymphoma. The trial should compare epcoritamab monotherapy to an investigator’s choice of standard therapies for patients with relapsed or refractory large B-cell lymphoma. The primary endpoint should be OS with secondary endpoints that include PFS and response rate.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell
source cells exact
  1. links
      text
      Epkinly (epcoritamab-bysp)
    1. links
      1. /drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell
      text
      Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
    2. links
        text
        5/19/2023
      1. links
          text
          4435-1: Complete a randomized clinical trial in patients with relapsed or refractory large B-cell lymphoma. The trial should compare epcoritamab monotherapy to an investigator’s choice of standard therapies for patients with relapsed or refractory large B-cell lymphoma. The primary endpoint should be OS with secondary endpoints that include PFS and response rate.
        1. links
            text
            6/30/2025
          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
          31
          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
          2023-05-19
          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
            Epkinly (epcoritamab-bysp)
            fda status record id
            fda-aa-54f8004f5a784e287b01
            indication exact
            Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-d9a171c6475dc2876a0e
            2. ind-span-d08a783e1aa9f6b087c1
            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-b36e57812095f606022a7c50
              span id
              ind-span-d9a171c6475dc2876a0e
              status id
              fda-aa-54f8004f5a784e287b01
              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
              343
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
              label id
              e2f39a72-c677-4ded-a10c-da739f457180
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              effec78d5709b278e74da8e1d842442ee08b203282ff937213c7bdb0a19359a1
              start
              0
              fda indication exact
              Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
              fda source row index
              31
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-54f8004f5a784e287b01
              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
              2023-05-19
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-ee3b54e1928603c546063c83
                span id
                ind-span-d08a783e1aa9f6b087c1
                status id
                fda-aa-54f8004f5a784e287b01
                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
                1190
                end exclusive
                true
                exact text
                1.1 DLBCL and High-grade B-cell Lymphoma EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
                label id
                e2f39a72-c677-4ded-a10c-da739f457180
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                effec78d5709b278e74da8e1d842442ee08b203282ff937213c7bdb0a19359a1
                start
                877
                fda indication exact
                Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
                fda source row index
                31
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
                fda-aa-54f8004f5a784e287b01
                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
                2023-05-19
                supporting anchor spans

                Preserved source evidence · Not medical advice