Clovis Oncology Inc.'s breakthrough-designated lung cancer drug Xegafri (rociletinib) is expected to face a challenging FDA Oncologic Drugs Advisory Committee review April 12 on three fronts: efficacy, safety and appropriate dose.
Clovis is seeking accelerated approval for the treatment of patients with EGFR mutation-positive non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and who have the T790M mutation as detected by an FDA approved test