TriangleSTATUS · fda-aa-fee291a81445048feb08
Enhertu (fam-trastuzumab deruxtecan-nxki)
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 unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- Source status category
- ongoing
- Event date
- 2024-04-05
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2024-04-05
- accelerated approval date source text
- 4/5/2024
- brand name hint
- Enhertu
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Enhertu (fam-trastuzumab deruxtecan-nxki)
- generic name hint
- fam-trastuzumab deruxtecan-nxki
- id
- fda-aa-fee291a81445048feb08
- indication exact
- Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- original projected completion source text
- 6/30/2027
- post marketing requirement exact
- 4624-1: Complete Cohort A in Part 2 of the ongoing DESTINY-PanTumor02 trial intended to verify and describe the clinical benefit of Enhertu in adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors that have progressed following prior treatment and have no satisfactory alternative treatment options. Include a minimum of 40 patients across all tumor types, other than breast, colorectal, lung, and gastric/GEJ cancer, including a sufficient number of patients with and representation of HER2-positive (IHC3+) tumor types that require additional characterization. In order to characterize response rate and duration of response, patients should be followed for at least 12 months from the onset of response.
- record type
- fda_accelerated_approval_status_row
- source cells exact
- links
- text
- Enhertu (fam-trastuzumab deruxtecan-nxki)
- links
- /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2
- text
- Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- links
- text
- 4/5/2024
- links
- text
- 4624-1: Complete Cohort A in Part 2 of the ongoing DESTINY-PanTumor02 trial intended to verify and describe the clinical benefit of Enhertu in adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors that have progressed following prior treatment and have no satisfactory alternative treatment options. Include a minimum of 40 patients across all tumor types, other than breast, colorectal, lung, and gastric/GEJ cancer, including a sufficient number of patients with and representation of HER2-positive (IHC3+) tumor types that require additional characterization. In order to characterize response rate and duration of response, patients should be followed for at least 12 months from the onset of response.
- links
- text
- 6/30/2027
- source provenance
- bytes
- 102185
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- 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
- 24
- source table headers
- Drug Name
- Accelerated Approval (AA) Indication
- AA Date
- AA Post-Marketing Requirement
- 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
- 2024-04-05
- 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
- Enhertu (fam-trastuzumab deruxtecan-nxki)
- fda status record id
- fda-aa-fee291a81445048feb08
- indication exact
- Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-b475390cb5f9ae83e8cc
- source provenance
- bytes
- 102185
- effective url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- file
- /private/tmp/cancer-full-research/indications/raw/accelerated-ongoing.html
- http status
- 200
- requested url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- 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 url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- status category
- ongoing
- unmatched meaning
- Source null
- links
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-bc8615e9b96a148069bee83e
- span id
- ind-span-b475390cb5f9ae83e8cc
- status id
- fda-aa-fee291a81445048feb08
- 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
- 6342
- end exclusive
- true
- exact text
- 1.6 HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors ENHERTU, as monotherapy, is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- label id
- a4106ba4-f398-4663-980c-2b7195283edd
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- f46f76b3066b69e4fe9aca60db8731449d2fbab724b9f8c0bed01fc917e7f90d
- start
- 6035
- fda indication exact
- Adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
- fda source row index
- 24
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-fee291a81445048feb08
- 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
- source url
- https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
- status category
- ongoing
- status event date
- 2024-04-05
- supporting anchor spans
Preserved source evidence · Not medical advice