Traditionally, each would require a separate regulatory approval pathway to demonstrate clinical value compared to the currently accepted standard of care treatment regimens, despite harboring a B-RAF mutational lesion, Hence, blanket approval for vemurafenib across all tumor indications harboring a B-RAF mutation was not reasonable, since a randomized trial against standard of care would be required for each indication to demonstrate clinical value. The gene discussed is BRAF; the disease is neoplasm.