To provide access to rociletinib for patients with advanced or metastatic EGFR-mutant NSCLC who have been treated previously with EGFR-directed therapy and have evidence of a T790M mutation (T790M+).
Must have documented evidence of one or more activating EGFR mutations (excluding the exon 20 insertion mutation) and the T790M resistance mutation.
Prior treatment with an approved or experimental EGFR-directed therapy.
Requirement of therapy due to disease progression confirmed by radiologic and/or clinical assessment and/or intolerance to prior EGFR-directed therapy.