TriangleSTATUS · fda-aa-40bc166a9eb4fa84cb99
Modeyso (dordaviprone)
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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 adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- Source status category
- ongoing
- Event date
- 2025-08-06
- Meaning of this date
- Original accelerated approval date; ongoing status observed at source retrieval
- accelerated approval date
- 2025-08-06
- accelerated approval date source text
- 8/6/2025
- brand name hint
- Modeyso
- date change comparison status
- no_previous_normalized_snapshot_supplied
- date change from prior snapshot
- Source null
- drug name exact
- Modeyso (dordaviprone)
- generic name hint
- dordaviprone
- id
- fda-aa-40bc166a9eb4fa84cb99
- indication exact
- Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- original projected completion source text
- 7/31/2031
- post marketing requirement exact
- 4861-1: Complete a multiregional, randomized clinical trial in patients with H3 K27M-mutant diffuse midline glioma, intended to verify and describe the clinical benefit of dordaviprone through assessment of overall survival (OS) as a primary endpoint. 4861-2: Conduct a clinical trial in pediatric patients (<17 years of age) with H3 K27M-mutant diffuse midline glioma, inclusive of a sufficient number of patients with Diffuse Intrinsic Pontine Glioma (DIPG), intended to verify and describe the clinical benefit of dordaviprone in the pediatric population. Endpoints evaluated should include overall response rate (ORR), duration of response (DOR), and overall survival (OS).
- record type
- fda_accelerated_approval_status_row
- related fda urls
- source cells exact
- links
- text
- Modeyso (dordaviprone)
- links
- /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dordaviprone-diffuse-midline-glioma
- text
- Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- links
- text
- 8/6/2025
- links
- text
- 4861-1: Complete a multiregional, randomized clinical trial in patients with H3 K27M-mutant diffuse midline glioma, intended to verify and describe the clinical benefit of dordaviprone through assessment of overall survival (OS) as a primary endpoint. 4861-2: Conduct a clinical trial in pediatric patients (<17 years of age) with H3 K27M-mutant diffuse midline glioma, inclusive of a sufficient number of patients with Diffuse Intrinsic Pontine Glioma (DIPG), intended to verify and describe the clinical benefit of dordaviprone in the pediatric population. Endpoints evaluated should include overall response rate (ORR), duration of response (DOR), and overall survival (OS).
- links
- text
- 7/31/2031
- 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
- 9
- 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
- 2025-08-06
- 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
- Modeyso (dordaviprone)
- fda status record id
- fda-aa-40bc166a9eb4fa84cb99
- indication exact
- Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- match status
- source_correspondence_found_clinical_review_pending
- matched candidate ids
- ind-span-338dd4cfc7150b08152a
- ind-span-9ffee6f7998f6889a139
- 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-31d940f43b6f344016a5046c
- span id
- ind-span-9ffee6f7998f6889a139
- status id
- fda-aa-40bc166a9eb4fa84cb99
- 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
- 732
- end exclusive
- true
- exact text
- MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- label id
- 9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- e96d3f0a8f53c305f38b174595c7fdd4cbdf01b3de266c44cdc45dd19d6f8534
- start
- 509
- fda indication exact
- Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- fda source row index
- 9
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-40bc166a9eb4fa84cb99
- 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
- 2025-08-06
- supporting anchor spans
- package id
- fda-label-library-8184721b7b3bb86692f8276c
- correspondence id
- correspondence-5cde5f5bb13221084f8c960d
- span id
- ind-span-338dd4cfc7150b08152a
- status id
- fda-aa-40bc166a9eb4fa84cb99
- 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
- 226
- end exclusive
- true
- exact text
- 1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- label id
- 9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- e96d3f0a8f53c305f38b174595c7fdd4cbdf01b3de266c44cdc45dd19d6f8534
- start
- 0
- fda indication exact
- Treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
- fda source row index
- 9
- fda source sha256
- 8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
- fda status record id
- fda-aa-40bc166a9eb4fa84cb99
- 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
- 2025-08-06
- supporting anchor spans
Preserved source evidence · Not medical advice