Drug updated on 10/17/2024
| Dosage Form | Tablet (oral; 100 mg); Suspension (oral; 25 mg/mL) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric lowgrade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- The Overall Response Rate (ORR) in Arm 1 was 67%, based on RANO-HGG criteria, with a median Duration of Response (DOR) of 16.6 months and a median Time to Response (TTR) of 3.0 months.
- According to RAPNO criteria, the ORR, including minor responses, was 51%, with a median DOR of 13.8 months and a median TTR of 5.3 months.
- The study population consisted of pediatric patients with relapsed/refractory low-grade glioma and BRAF genomic alterations.
- Treatment-related adverse events (TRAEs) included hair color changes (76%), elevated creatine phosphokinase (56%), and anemia (49%).
- Grade ≥3 TRAEs occurred in 42% of patients, and 7% (9 patients) discontinued tovorafenib due to adverse events.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Ojemda (tovorafenib) Prescribing Information. | 2024 | Day One Biopharmaceuticals, Inc., Brisbane CA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial | 137Subjects F: 47% M: 53% | 2024 | Nature Medicine |
Document Title
Sex Distribution:
F:47%
M:53%
137Subjects
Year:
2024
Source:Nature Medicine