The U.S, Based Array BioPharma received FDA approval for its much-awaited BRAFTOVI capsules with the combination of MEKTOVI tablets for the treatment of patients with metastatic melanoma with a BRAFV600E or BRAFV600K mutation.
Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation.
Melanoma, a cancer of skin pigment cells called melanocytes, will strike an estimated 87,110 people in the U.S. in 2017, according to the Centers for Disease Control and Prevention. A fraction of those melanomas come from pre-existing moles, but the majority of them come from sources unknown - until now.
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