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Association details:
| Biomarker: | BRAF mutation |
|---|---|
| Cancer: | Glioma |
| Drug: | Ojemda (tovorafenib) (pan-RAF inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma
Excerpt:
...Patients must be aged 6 months to 25 years, inclusive, with a relapsed or progressive low-grade glioma with a documented known or expected to be activating BRAF mutation or RAF fusion, as identified through molecular assays as routinely performed at CLIA-certified or other similarly certified laboratories....
Trial ID:
Source:
Title:
The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial
Published date:
11/17/2023
Excerpt:
Arm 1 (n = 77) of the ongoing phase 2 FIREFLY-1 (PNOC026) trial investigated the efficacy of the oral, selective, central nervous system–penetrant, type II RAF inhibitor tovorafenib (420 mg m−2 once weekly; 600 mg maximum) in patients with BRAF-altered, relapsed/refractory pLGG. Arm 2 (n = 60) is an extension cohort, which provided treatment access for patients with RAF-altered pLGG after arm 1 closure.... The ORR according to RAPNO criteria (including minor responses) was 51%; median DOR was 13.8 months; and median TTR was 5.3 months....These data indicate that tovorafenib could be an effective therapy for BRAF-altered, relapsed/refractory pLGG.
DOI:
https://doi.org/10.1038/s41591-023-02668-y
Trial ID:
