New Primary Malignancies
Cutaneous Malignancies
In the pooled adult safety population of TAFINLAR administered with MEKINIST (“the combination”), the incidence of cutaneous squamous cell carcinoma (cuSCC, including keratoacanthomas) occurred in 2% of patients. Basal cell carcinoma and new primary melanoma occurred in 3% and <1% of patients, respectively.
Perform dermatologic evaluations prior to initiation of the combination, every 2 months while on therapy, and for up to 6 months following discontinuation.
TAFINLAR, in combination with MEKINIST, is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
TAFINLAR, in combination with MEKINIST, is indicated 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.
Limitation of Use: TAFINLAR is not indicated for the treatment of patients with wild-type BRAF melanoma.