Clovis Oncology, Inc. Announced That The U.S. Food And Drug Administration (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 That The Fda Wait To See Results From Tiger-3, Clovis’ Ongoing Phase 3, 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.
