What changed: Paediatric low-grade glioma
Every dated change on the records linked to Paediatric low-grade glioma, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
September 2026 · 1
2026 · 1
2024 · 3
- 2024ApprovalTovorafenibTovorafenib approved in US
Relapsed/refractory BRAF-altered paediatric low-grade glioma (accelerated)
- 2024GuidelinePaediatric low-grade gliomaGuideline FDA accelerated approval 2024: Relapsed or refractory, BRAF fusion or V600E
Tovorafenib (FIREFLY-1; FDA accelerated approval April 2024 for patients aged six months and over), or a MEK inhibitor such as selumetinib in trials.
- 2024MilestoneTovorafenibTovorafenib approved for relapsed BRAF-altered pLGG
FIREFLY-1 (Nature Medicine 2024) shows durable responses across fusions and V600E; FDA accelerated approval April 2024.
2023 · 4
- 2023GuidelinePaediatric low-grade gliomaGuideline FDA label 2023; NCI PDQ: Unresectable or progressive, BRAF V600E
Dabrafenib plus trametinib first line (TADPOLE: higher response rate and longer progression-free survival than carboplatin-vincristine; FDA approval March 2023 for patients aged one year and over).
- 2023Trial resultFIREFLY-1FIREFLY-1 reported
ORR 67% (RANO-HGG) and 51% (RAPNO-LGG) in arm 1; median DOR 16.
- 2023Trial resultTADPOLE (CDRB436G2201)TADPOLE (CDRB436G2201) reported
ORR 47% vs 11%; median PFS 20.
- 2023MilestoneDabrafenib + trametinibTADPOLE: dabrafenib plus trametinib beats chemotherapy first line
Higher response rate and longer progression-free survival than carboplatin-vincristine in BRAF V600E pLGG (NEJM); FDA approval in March 2023.