This section contains excerpted1
information on gene-based dosing recommendations. Neither this section nor other parts of this review contain the complete recommendations from the sources.
2023 Statement from the US Food and Drug Administration (FDA):
BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma: Dabrafenib is indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma: Dabrafenib is indicated, in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.
Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma
Dabrafenib is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
BRAF V600E Mutation-Positive Metastatic NSCLC
Dabrafenib is indicated, in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test
BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer
Dabrafenib is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Dabrafenib is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options ... This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DoR) … Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
BRAF V600E Mutation-Positive Low-Grade Glioma
Dabrafenib is indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
Limitation of Use: Dabrafenib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition … Dabrafenib is not indicated for treatment of patients with wild-type BRAF solid tumors.
Patient Selection: Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with dabrafenib as a single agent. Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with dabrafenib and trametinib. Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics.
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Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency
Advise patients that dabrafenib may cause hemolytic anemia in patients with G6PD deficiency. Advise patients with known G6PD deficiency to contact their healthcare provider to report signs or symptoms of anemia or hemolysis.
Please review the complete therapeutic recommendations that are located here:
(1).