Brief: Clovis Oncology Inc Says On Nov 14, At Request Of FDA, Co Met With FDA To Discuss The Overall Survival Data From The Co's ARIEL3 Clinical Trial

Clovis Oncology

16/11/2022 22:37

Nov 16 (Reuters) - Clovis Oncology Inc  CLVS.O :
    * CLOVIS ONCOLOGY INC - ON NOV 14, AT REQUEST OF FDA, CO MET
WITH
FDA TO DISCUSS THE OVERALL SURVIVAL DATA FROM THE CO’S ARIEL3
CLINICAL TRIAL
    * CLOVIS - FDA REQUESTED CO VOLUNTARILY REVISE LABEL TO
LIMIT
INDICATION OF RUBRACA IN THIS SECOND-LINE MAINTENANCE TREATMENT
TO TBRCA PATIENTS ONLY
    * CLOVIS - FDA FURTHER INDICATED TO CO THAT IF AN AGREEMENT
COULD
NOT BE REACHED ON REVISED INDICATION, FDA WOULD CONVENE ODAC
MEETING TO REVIEW MATTER
    * CLOVIS - COMPANY IS CURRENTLY EVALUATING FDA’S REQUEST

Further company coverage:  CLVS.O 
 ((Reuters.Briefs@thomsonreuters.com;))