The European Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion of AbbVie's Venclyxto (venetoclax) tablets for the treatment of chronic lymphocytic leukemia (CLL).
CHMP recommends the product for the treatment of 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.
The committee also recommends the product for treatment 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.
"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," Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, said. "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."
