April 23, 2018 / 10:15 PM / 7 months ago

BRIEF-Epizyme Provides Update Regarding Tazemetostat Clinical Program

April 23 (Reuters) - Epizyme Inc:

* EPIZYME PROVIDES UPDATE REGARDING TAZEMETOSTAT CLINICAL PROGRAM

* U.S.-BASED ENROLLMENT OF NEW PATIENTS INTO TAZEMETOSTAT CLINICAL TRIALS IS TEMPORARILY ON HOLD

* PATIENTS ON STUDY WHO HAVE NOT EXPERIENCED DISEASE PROGRESSION MAY CONTINUE TO RECEIVE TAZEMETOSTAT

* EPIZYME HAS BEGUN DEVELOPING MODIFICATIONS TO ADDRESS PARTIAL CLINICAL HOLD

* CO WILL NEED TO CONFIRM ALIGNMENT WITH FDA IN ORDER TO RESUME U.S. ENROLLMENT

* EPIZYME -U.S. FDA ISSUED PARTIAL CLINICAL HOLD AFFECTING NEW ENROLLMENT OF PATIENTS WITH GENETICALLY DEFINED SOLID TUMORS AND HEMATOLOGIC MALIGNANCIES

* PARTIAL CLINICAL HOLD WAS INITIATED FOLLOWING A SAFETY REPORT, SUBMITTED BY EPIZYME TO FDA AND OTHER REGULATORY AUTHORITIES

* EPIZYME-REPORT WAS REGARDING A PATIENT WITH ADVANCED POORLY DIFFERENTIATED CHORDOMA IN PHASE 1 PEDIATRIC STUDY WHO DEVELOPED SECONDARY T-CELL LYMPHOMA

* PATIENT WHO DEVELOPED A SECONDARY T-CELL LYMPHOMA HAS NOW DISCONTINUED TAZEMETOSTAT AND IS BEING TREATED FOR T-CELL LYMPHOMA Source text for Eikon: Further company coverage:

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