Edition:
United Kingdom

AbbVie Says FDA Placed A Partial Clinical Hold On All Clinical Trials Evaluating Venetoclax For Investigational Treatment Of Multiple Myeloma


Tuesday, 19 Mar 2019 

March 19 (Reuters) - AbbVie Inc ::ABBVIE PROVIDES UPDATE ON VENCLEXTA®/VENCLYXTO® (VENETOCLAX) MULTIPLE MYELOMA PROGRAM.ABBVIE INC - FDA HAS PLACED A PARTIAL CLINICAL HOLD ON ALL CLINICAL TRIALS EVALUATING VENETOCLAX FOR INVESTIGATIONAL TREATMENT OF MULTIPLE MYELOMA.ABBVIE INC - PARTIAL CLINICAL HOLD FOLLOWS A REVIEW OF DATA FROM ONGOING PHASE 3 BELLINI TRIAL (M14-031).ABBVIE INC - TUESDAY'S ACTION DOES NOT IMPACT ANY OF APPROVED INDICATIONS FOR VENETOCLAX.ABBVIE - PATIENTS WHO ARE CURRENTLY ENROLLED IN STUDIES AND RECEIVING BENEFIT FROM THERAPY MAY CONTINUE WITH TREATMENT, AFTER CONSULTATION WITH PHYSICIAN.ABBVIE INC - INFORMED CLINICAL TRIAL INVESTIGATORS INVOLVED IN STUDIES OF RESULTS AND WILL WORK WITH THEM TO PROCEED AS APPROPRIATE.ABBVIE - A HIGHER PROPORTION OF DEATHS WAS OBSERVED IN VENETOCLAX ARM COMPARED TO CONTROL ARM OF TRIAL IN PHASE 3 BELLINI TRIAL (M14-031).