The approval allows more patients to be treated with Venclyxto in the second-line setting while giving healthcare providers the ability to prescribe the drug to a larger population of R/R CLL patients compared to the earlier approved indication of the drug as a monotherapy in the European Union (EU).
Venclyxto, which selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein, is being developed by AbbVie and Roche.
MabThera, which is owned by Roche, is a monoclonal antibody that target cells having the CD20 marker on their surface.
The approval of the combination covers 28 member states of the EU, along with Iceland, Liechtenstein and Norway. It comes in the wake of a positive opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP) in September 2018 for the marketing authorization application of the combination therapy for the intended indication.
Roche chief medical officer and global product development head Sandra Horning said: “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.
“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.”
The EC approval for the AbbVie and Roche combination therapy has been driven by the data from the MURANO phase 3 trial.
The late-stage trial showed that the combination of Venclyxto with MabThera reduced the risk of disease progression or death by 83% in comparison to a standard of care chemoimmunotherapy in previously treated CLL.
AbbVie research and development executive vice president and chief scientific officer Michael Severino said: “The approval of Venclyxto in combination with rituximab is an important step forward in providing patients with relapsed/refractory chronic lymphocytic leukemia a strong chance to live longer without their disease progressing.
“We look forward to bringing Venclyxto to more patients with chronic lymphocytic leukemia, while continuing to further the research and development of therapies with the potential to transform the standards of care in blood cancers.”