CHMP grants positive opinion for Venetoclax tablets for patients with difficult-to-treat chronic lymphocytic leukaemia
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.
Chronic lymphocytic leukaemia 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% of previously untreated CLL cases and up to 30 to 50% of relapsed or refractory CLL cases.
A TP53 mutation occurs in 8 to 15% of patients at first-line treatment and up to 35 to 50% of cases in refractory chronic lymphocytic leukaemia.
Those with the 17p deletion or TP53 mutations often have a particularly poor prognosis and a median life expectancy of less than two to three years with current standard-of-care regimens.
Recently, the Committee for Orphan Medicinal Products ( COMP ) of the EMA adopted positive opinions on Orphan Drug Designation applications for Venclyxto for the treatment of multiple myeloma, a type of cancer that forms in plasma cells in bone marrow, and for diffuse large B-cell lymphoma ( DLBCL ), an aggressive type of lymphoma and the most common form of non-Hodgkin lymphoma ( NHL ).
Previously, the EMA granted Orphan Drug Designation to Venclyxto for the treatment of chronic lymphocytic leukaemia and for the treatment of acute myeloid leukaemia (AML), the most common type of acute leukaemia in adults.
Venetoclax is an investigational oral B-cell lymphoma-2 ( BCL-2 ) inhibitor being evaluated for the treatment of patients with various blood cancer types. The BCL-2 protein prevents apoptosis ( programmed cell death ) of some cells, including lymphocytes, and can be overexpressed in some cancer types.
Venetoclax, which is given once daily, is designed to selectively inhibit the function of the BCL-2 protein. ( Xagena )
Source: Abbvie, 2016