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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.
Relapsed/refractory BRAF-altered paediatric low-grade glioma (accelerated)
Tovorafenib (FIREFLY-1; FDA accelerated approval April 2024 for patients aged six months and over), or a MEK inhibitor such as selumetinib in trials.
FIREFLY-1 (Nature Medicine 2024) shows durable responses across fusions and V600E; FDA accelerated approval April 2024.
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).
ORR 67% (RANO-HGG) and 51% (RAPNO-LGG) in arm 1; median DOR 16.
ORR 47% vs 11%; median PFS 20.
Higher response rate and longer progression-free survival than carboplatin-vincristine in BRAF V600E pLGG (NEJM); FDA approval in March 2023.
With trametinib: BRAF V600E/K metastatic melanoma; later adjuvant melanoma, BRAF V600E NSCLC, anaplastic thyroid cancer, tumour-agnostic solid tumours and paediatric low-grade glioma
With dabrafenib: metastatic melanoma; later adjuvant melanoma, NSCLC, anaplastic thyroid cancer, tumour-agnostic BRAF V600E solid tumours, paediatric low-grade glioma