FDA Advisory Committee does not approve NDA for rociletinib to treat NSCLC with T790M mutation- Clovis Oncology
Clovis Oncology has announced that the FDA Oncologic Drugs Advisory Committee (ODAC) met to discuss approval of the New Drug Application (NDA) for rociletinib, an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation.
The Committee recommended (12 votes to 1) that the FDA wait to see results from TIGER-3, Clovis’ ongoing Phase III, randomized, controlled trial of rociletinib, before making a decision on approval of the treatment. Patient enrollment for the trial is expected to complete in late 2018.
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