FDA label
What is Tafinlar used for?
Tafinlar contains dabrafenib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Tafinlar lists 7 uses: BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma; BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma; Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma; BRAF V600E Mutation-Positive Metastatic NSCLC; and 3 more.
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Tafinlar, capsule
Indications and Usage, quoted from the label by Novartis Pharmaceuticals Corporation (NDA202806). Cross-references to other label sections are left out.
BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma
TAFINLAR® 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
TAFINLAR 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
TAFINLAR 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
TAFINLAR 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
TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test, and with no satisfactory locoregional treatment options.
BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
TAFINLAR is indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year 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
TAFINLAR 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.
Limitations of Use
- TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
- TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors.
Source: DailyMed label, set id fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea, version 37, effective May 20, 2026. NDC 0078-0681, one of 2 listings for this product.
Questions
What is Tafinlar used for?
The FDA label for Tafinlar lists 7 uses: BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma; BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma; Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma; BRAF V600E Mutation-Positive Metastatic NSCLC; and 3 more.
What drug class is Tafinlar?
FDA lists dabrafenib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.