Clovis Oncology (CLVS) Confirms Committee on Rociletinib Recommended FDA Wait to See Results from TIGER-3
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Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib for Treatment of Advanced T790M-Positive Mutant Epidermal Growth Factor Receptor Non-Small Cell
April 12, 2016 1:52 PM EDTBOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today 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... More
Trading of Clovis Oncology, Inc. Common Stock Halted
April 12, 2016 7:04 AM EDTFDAs Oncologic Drugs Advisory Committee to Review Rociletinib New Drug Application for the Treatment of Non-Small Cell Lung Cancer
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that NASDAQ has halted trading of the Companys common stock. The U.S. Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee (ODAC) is meeting this morning to discuss the companys New Drug Application (NDA) for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who... More
