in association with vemurafenib, for first-line or second-line treatment following a failure with cytotoxic chemotherapy or with immunotherapy targeting the PD-1 or the CTLA-4, of an unresectable or metastatic melanoma with a BRAF V600 mutation, in persons whose ECOG performance status is 0 or 1.
The initial authorization is for a maximum duration of four months.
Upon subsequent requests, the physician must provide evidence of a beneficial clinical effect defined by the absence of disease progression, confirmed by imaging or by a physical examination. The ECOG performance status must remain at 0 or 1. Subsequent authorizations will be for durations of four months.
Authorizations are given for a maximum daily dose of 60 mg during 21 consecutive days per 28-day cycle.