GlaxoSmithKline, a research-based pharmaceutical and healthcare company, announced the FDA has approved both Tafinlar (dabrafenib) and Mekinist (trametinib).

Tafinlar is indicated as a single-agent oral treatment for unresectable melanoma (melanoma that cannot be removed by surgery) or metastatic melanoma (melanoma which has spread to other parts of the body) in adult patients with BRAF V600E mutation. Tafinlar is not indicated for the treatment of patients with wild-type BRAF melanoma.

Mekinist is indicated as a single-agent oral treatment for unresectable or metastatic melanoma in adult patients with BRAF V600E or V600K mutations. Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy. These mutations must be detected by an FDA-approved test, such as the companion diagnostic assay from bioMerieux S.A., THxID-BRAF.

"With today's FDA approvals, GSK can now offer two new single-agent therapies to selected patients who have metastatic melanoma, a devastating disease with very low survival rates and few treatment options," said Paolo Paoletti, M.D., president, GSK oncology.

Among those with metastatic melanoma, approximately half have a BRAF mutation, which is an abnormal change in a gene that can enable some melanoma tumors to grow and spread. Tafinlar and Mekinist are each approved for patients with the BRAF V600E mutation, which accounts for approximately 85% of all BRAF V600 mutations in metastatic melanoma. Mekinist is also approved for patients with the V600K mutation, which makes up approximately 10% of all BRAF V600 mutations in metastatic melanoma.

"MEK has been pursued as a therapeutic target in cancer for more than a decade," said Keith Flaherty, M.D., director of developmental therapeutics, Massachusetts General Hospital Cancer Center, and principal investigator of the phase III Metric trial. "Based on the clear improvement versus chemotherapy in progression-free survival, trametinib represents the first
validated MEK inhibitor."

In 2010, GSK entered a collaboration with bioMerieux to develop a companion diagnostic test to detect BRAF V600 (V600E and V600K) gene mutations found in several cancers, including melanoma. bioMerieux has received FDA pre-market approval of THxID(TM)-BRAF. Currently, it is the only FDA-approved test that detects the V600K mutation.