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Scorecard version: 1

Indication details

Tumour Type
Brain Tumours
Tumour Sub-type
Glioma (high grade)
Tumour Sub-Group
Tumour stage
Unresectable or metastatic
Control Arm
Single arm (Phase II)
Treatment Setting
For the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options
Trial Name

Primary Outcome(s)

Primary Outcome(s)
Investigator-assessed ORR
Evaluated Outcome
Form 3

Outcome Data

PFS Control
3.8 months
36.9 months

Final Score (after adjustments)

Preliminary non-curative score
Final non-curative Score
FDA accelerated approval June 2022
Issue date
Release date

ChT; chemotherapy; DFS, disease-free survival; DoR, duration of response; EFS, event-free survival; FFS, failure-free survival; HR, hazard ratio; HRD, homologus recombination deficiency; HRP, homologous recombination proficient; iDFS, invasive disease-free survival; ITT, intention to treat; MFS, metastasis-free survival; NS, not significant; ORR, overall response rate; OS, overall survival; pCR, pathologic complete response.remission; PE, point estimate; PFS, progression-free survival; QoL, quality of life; RFS, relapse-free survival; RR, response rate; rPFS, radiographic progression-free survival; SD, stable disease; SSA, somatostatin analogue; SSTR, somatostatin receptor; TKI, tyrosine kinase inhibitor, TTP, time to progression; WT, wild type

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