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.
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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.
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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.
