The document details the FDA's tentative approval of Binimetinib Tablets, 15 mg, a generic version of Mektovi, indicating its bioequivalence and therapeutic equivalence to the reference drug, though final approval is delayed due to patent and exclusivity restrictions.

Therapeutic Role of Binimetinib: A MEK Inhibitor in Oncology Treatment

Binimetinib, the active ingredient in the tentatively approved generic formulation referenced in ANDA 217678, is a selective MEK1/2 inhibitor. Clinically, its therapeutic effect is aligned with that of the reference listed drug, Mektovi (Array Biopharma), and is primarily indicated for the treatment of unresectable or metastatic melanoma harboring BRAF V600E or V600K mutations, in combination with BRAF inhibitors. It exerts its effect by disrupting the MAPK/ERK signaling pathway, a key driver in cell proliferation and survival in certain cancers. While the FDA recognizes its bioequivalence, the document does not specify new clinical data; rather, it references existing therapeutic equivalence.