MEKINIST is a kinase inhibitor indicated as a single agent for the treatment
of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic
melanoma with BRAF V600E or V600K mutations as detected by an FDA approved
test.
MEKINIST is indicated, in combination with dabrafenib, for:
• the treatment of patients with unresectable or metastatic melanoma with
BRAF V600E or V600K mutations as detected by an FDA-approved
test.
• 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.
• the treatment of patients with metastatic non-small cell lung cancer
(NSCLC) with BRAF V600E mutation as detected by an FDA-approved
test.
• the treatment of patients with locally advanced or metastatic anaplastic
thyroid cancer (ATC) with BRAF V600E mutation and with no
satisfactory locoregional treatment options.
• 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 and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory trial(s).
