AbbVie Receives CHMP Positive Opinion for VENCLYXTO™ (venetoclax) Tablets for Appropriate Patients with Difficult-To-Treat Chronic Lymphocytic Leukaemia

- CHMP recommends VENCLYXTO monotherapy for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor

- If granted conditional marketing authorization by the European Commission, VENCLYXTO would become the first approved BCL-2 inhibitor in Europe

- COMP recently adopted positive opinions for VENCLYXTO Orphan Drug Designation for the treatment of multiple myeloma and diffuse large B-cell lymphoma (DLBCL)

NORTH CHICAGO, Illinois, Oct. 14, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for VENCLYXTO™ (venetoclax) tablets for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor; and for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo-immunotherapy and a B-cell receptor pathway inhibitor. The European Commission will review the opinion and make a final decision in late 2016. VENCLYXTO is being developed by AbbVie and Genentech, a member of the Roche Group.

"People living with CLL who have failed other treatments or who harbor the 17p deletion or TP53 mutation have limited options and typically a poor prognosis. Today's CHMP positive opinion marks a major step forward for these patients," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "This innovation delivers on AbbVie's promise to develop cancer medicines where an unmet need exists. We will continue to work with European regulators to make venetoclax available to appropriate CLL patients."

CLL, a cancer of the bone marrow and blood, is typically a slow-progressing cancer. The 17p deletion – a genomic alteration in which a part of chromosome 17 is absent – is found in 3 to 10 percent of previously untreated CLL cases and up to 30 to 50 percent of relapsed or refractory CLL cases.¹ A TP53 mutation occurs in 8 to 15 percent of patients at first-line treatment and up to 35 to 50 percent of cases in refractory CLL.¹ Those with the 17p deletion or TP53 mutations often have a particularly poor prognosis¹ and a median life expectancy of less than two to three years with current standard-of-care regimens.²