Special Drug Use-results Surveillance of Tafinlar/Mekinist

This is a prospective, multicenter, single-arm, non-interventional and observational
J-PMS conducted by the central registration system and operated in Electronic data
capture. In the Post-Marketing Surveillance (PMS), dabrafenib and trametinib are used as the
marketed drugs. Registration of the corresponding patients is to be conducted by the
central registered system under current medical practice.

Target number of adult patient is 65 (as the number of patients in the effectiveness
analysis set).

Target number of pediatric patient is not determined. Estimated number of enrolled
patients is approximately 20 (as the number of patients in the enrolled set)

The observation period for pediatric patients will last after the start of treatment
until 8 years (planned, November 2031) after the approval of additional indications,
regardless of discontinuation of the product, in order to collect long-term information
from as many patients as possible during the reexamination period. The duration of
observation for adult patients will be 1 year after the start of treatment with the
product.