trametinib and dabrafenib
Trametinib is an antineoplastic agent indicated as a single agent for the treatment of treatment-naïve patients with BRAF V600E or V600K-mutated unresectable or metastatic melanoma as tested in an FDA-approved trial. When used in combination with dabrafenib, it is indicated for: 1. Treatment of patients with unresectable or metastatic melanoma whose BRAF V600E or V600K mutations have been detected in an FDA-approved test. 2. Adjuvant therapy for patients with melanoma with BRAF V600E or V600K mutations and involved lymph nodes after complete resection based on an FDA-approved test. 3. Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose BRAF V600E mutation has been detected in an FDA-approved trial. 4. Treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) who have BRAF V600E mutations and no satisfactory locoregional treatment options. 5. Treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic BRAF V600E-mutant solid tumors who have progressed after prior therapy and for whom satisfactory alternative treatment options are not available. This indication received accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and characterization of clinical benefit in confirmatory trials. 6. Treatment of pediatric patients 1 year of age and older with BRAF V600E-mutated low-grade glioma (LGG) who require systemic therapy.
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