MEKINIST (trametinib) tablets, for oral use. Initial U.S. Approval: 2013

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MEKINIST (trametinib) tablets, for oral use. Initial U.S. Approval: 2013

INDICATIONS AND USAGE
MEKINIST is a kinase inhibitor indicated as a single agent and 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 use in combination is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib.
Limitation of use: MEKINIST as a single agent is not indicated for treatment of patients who have received prior BRAF-inhibitor therapy.
DOSAGE FORMS & STRENGTHS
Tablets: 0.5 mg, 1 mg, and 2 mg
Manufactured By: GlaxoSmithKline
Prescribing Information URL: Click Here

Access to MEKINIST (trametinib) tablets: Anticancer drugs available upon request. To get best price please share your mobile number to receive quotes from Medvitaz Pharma Solutions.

In May 2013, trametinib was approved as a single-agent by the Food and Drug Administration for the treatment of patients with V600E mutated metastatic melanoma. Clinical trial data demonstrated that resistance to single-agent trametinib often occurs within 6 to 7 months. To overcome this, trametinib was combined with the BRAF inhibitor dabrafenib.[4] As a result of this research, on January 8, 2014, the FDA approved the combination of dabrafenib and trametinib for the treatment of patients with BRAF V600E/K-mutant metastatic melanoma. On May 1, 2018, the FDA approved the combination dabrafenib/trametinib as an adjuvant treatment for BRAF V600E-mutated, stage III melanoma after surgical resection based on the results of the COMBI-AD phase 3 study, making it the first oral chemotherapy regimen that prevents cancer relapse for node positive, BRAF-mutated melanoma.

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