TriangleSTATUS · fda-aa-4923a44876544e9cc7af
Pemazyre (pemigatinib)
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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 adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- Source status category
- ongoing
- Event date
- 2020-04-17
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2020-04-17
- accelerated approval date source text
- 4/17/2020
- brand name hint
- Pemazyre
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Pemazyre (pemigatinib)
- generic name hint
- pemigatinib
- id
- fda-aa-4923a44876544e9cc7af
- indication exact
- Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- original projected completion source text
- 12/31/2026
- post marketing requirement exact
- 3801-1: Submit the results of a randomized trial demonstrating improvement of PFS or OS in patients with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 gene fusion or rearrangement, to confirm clinical benefit of pemigatinib.
- record type
- fda_accelerated_approval_status_row
- related fda urls
- source cells exact
- links
- text
- Pemazyre (pemigatinib)
- links
- text
- Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- links
- text
- 4/17/2020
- links
- text
- 3801-1: Submit the results of a randomized trial demonstrating improvement of PFS or OS in patients with unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 gene fusion or rearrangement, to confirm clinical benefit of pemigatinib.
- links
- text
- 12/31/2026
- 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
- 55
- 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
- 2020-04-17
- 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
- Pemazyre (pemigatinib)
- fda status record id
- fda-aa-4923a44876544e9cc7af
- indication exact
- Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-85e046263e71d5fc849c
- ind-span-f4419253c131e2a439ab
- 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-1dcf264a18b8f4b133685655
- span id
- ind-span-85e046263e71d5fc849c
- status id
- fda-aa-4923a44876544e9cc7af
- 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
- 299
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- label id
- 7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8c081b011711de18d6e9cf921bae10d56cdd73d2f7cadcd23d5d344c78a8e54b
- start
- 0
- fda indication exact
- Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- fda source row index
- 55
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-4923a44876544e9cc7af
- 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
- 2020-04-17
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-58ed49810100287c95d65927
- span id
- ind-span-f4419253c131e2a439ab
- status id
- fda-aa-4923a44876544e9cc7af
- 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
- 1022
- end exclusive
- true
- exact text
- 1.1 Cholangiocarcinoma PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test [see Dosage and Administration ( 2.1 )] .
- label id
- 7ab778c9-5f92-4e53-bfe8-8db8d3bd3ef3
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8c081b011711de18d6e9cf921bae10d56cdd73d2f7cadcd23d5d344c78a8e54b
- start
- 703
- fda indication exact
- Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
- fda source row index
- 55
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-4923a44876544e9cc7af
- 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
- 2020-04-17
- supporting anchor spans
Preserved source evidence · Not medical advice