1 INDICATIONS AND USAGE

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 [see Dosage and Administration (2.1)].

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 [see Dosage and Administration (2.1)].

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 [see Dosage and Administration (2.1)].

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 and with no satisfactory locoregional treatment options [see Dosage and Administration (2.1)].

Limitations of Use

Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF NSCLC, or wild-type BRAF ATC [see Warnings and Precautions (5.2)].