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STATUS · fda-aa-b8e386c11127f94bb465

Ojemda (tovorafenib)

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

Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

Source status category
ongoing
Event date
2024-04-23
Meaning of this date
Original accelerated approval date; ongoing status observed at source retrieval
accelerated approval date
2024-04-23
accelerated approval date source text
4/23/2024
brand name hint
Ojemda
date change comparison status
no_previous_normalized_snapshot_supplied
date change from prior snapshot
Source null
drug name exact
Ojemda (tovorafenib)
generic name hint
tovorafenib
id
fda-aa-b8e386c11127f94bb465
indication exact
Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
original projected completion source text
4/30/2032
post marketing requirement exact
4608-1: Conduct a multiregional, randomized clinical trial comparing tovorafenib to physician’s choice of chemotherapy in pediatric patients with low grade glioma with RAF fusions or rearrangements, or V600 mutations, intended to verify and describe the clinical benefit of tovorafenib through assessment of overall response rate (ORR) as a primary endpoint and progression-free survival (PFS) and duration of response, as determined by blinded independent central review, as key secondary endpoints. Include the protocol-specified ORR and interim PFS analyses in the interim report.
record type
fda_accelerated_approval_status_row
related fda urls
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-relapsed-or-refractory-braf-altered-pediatric
source cells exact
  1. links
      text
      Ojemda (tovorafenib)
    1. links
      1. /drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tovorafenib-patients-relapsed-or-refractory-braf-altered-pediatric
      text
      Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
    2. links
        text
        4/23/2024
      1. links
          text
          4608-1: Conduct a multiregional, randomized clinical trial comparing tovorafenib to physician’s choice of chemotherapy in pediatric patients with low grade glioma with RAF fusions or rearrangements, or V600 mutations, intended to verify and describe the clinical benefit of tovorafenib through assessment of overall response rate (ORR) as a primary endpoint and progression-free survival (PFS) and duration of response, as determined by blinded independent central review, as key secondary endpoints. Include the protocol-specified ORR and interim PFS analyses in the interim report.
        1. links
            text
            4/30/2032
          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
          23
          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
          2024-04-23
          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
            Ojemda (tovorafenib)
            fda status record id
            fda-aa-b8e386c11127f94bb465
            indication exact
            Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
            match status
            source_correspondence_found_clinical_review_pending
            matched candidate ids
            1. ind-span-b1c6ac39d0e0b84a2d4a
            2. ind-span-cf9c985b87d2f4d8d9d0
            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-487ac7cb121ffec27c72a1c1
              span id
              ind-span-b1c6ac39d0e0b84a2d4a
              status id
              fda-aa-b8e386c11127f94bb465
              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
              225
              end exclusive
              true
              exact text
              1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
              label id
              8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              689269789a612342cfa121785015ded55d2d311d0fccaeb16b8024affce2b85b
              start
              0
              fda indication exact
              Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
              fda source row index
              23
              fda source sha256
              8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
              fda status record id
              fda-aa-b8e386c11127f94bb465
              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
              2024-04-23
              supporting anchor spans
              1. package id
                fda-label-library-8184721b7b3bb86692f8276c
                correspondence id
                correspondence-7ba2ec33b5ca78e27f6c8aee
                span id
                ind-span-cf9c985b87d2f4d8d9d0
                status id
                fda-aa-b8e386c11127f94bb465
                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
                718
                end exclusive
                true
                exact text
                OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
                label id
                8bee41f8-a2d9-44ae-82a9-bd46b6f9916a
                offset unit
                unicode_code_points
                source array index
                0
                source field
                indications_and_usage_exact
                source text sha256
                689269789a612342cfa121785015ded55d2d311d0fccaeb16b8024affce2b85b
                start
                498
                fda indication exact
                Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
                fda source row index
                23
                fda source sha256
                8df28be8da28c19a2d63f9c7ada45adf8aa0a5f11be1a2b4df67ce8eea572def
                fda status record id
                fda-aa-b8e386c11127f94bb465
                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
                2024-04-23
                supporting anchor spans

                Preserved source evidence · Not medical advice