Roche says a combination of Venclyxto and MabThera has been approved in the European Union for people with previously treated chronic lymphocytic leukaemia.
The decision provides patients who have received at least one prior therapy a chemotherapy-free option to treat the disease.
Approval came after data from the Phase III MURANO study showed that fixed duration of treatment with Venclyxto (venetoclax) plus MabThera (rituximab) was well tolerated and cut the risk of disease progression or death by 83% versus a current standard of care.
“There are approximately 30,000 people living with chronic lymphocytic leukaemia in Europe, an incurable blood cancer that becomes harder to treat with each relapse,” said Sandra Horning, Roche’s chief medical officer and head of Global Product Development.
“We are pleased that, thanks to this approval, Venclyxto plus MabThera will provide a new chemotherapy-free option for people with previously treated chronic lymphocytic leukaemia, helping them to live longer without their disease progressing compared to a standard-of-care therapy.”
Venclyxto previously won conditional marketing authorisation in the EU in December 2016 as a single agent for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
The drug is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech in the US, under the brand name Venclexta, and commercialised by AbbVie outside of the US.