EU approve Venclyxto plus MabThera in leukaemia patients

NICE makes first immunotherapy combination immediately available in advanced kidney cancer within England via the Cancer Drugs Fund

Roche announces that the EC has approved Venclyxto plus MabThera for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). 

The European Commission has approved Venclyxto® (venetoclax) in combination with MabThera® (rituximab) for adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

This approval is based on results from the randomised phase III MURANO study which showed that a fixed duration of treatment with Venclyxto plus MabThera significantly reduced the risk of disease progression or death (progression-free survival [PFS] as assessed by investigators [INV], primary endpoint of the study) by 83% compared with bendamustine plus MabThera (BR), a current standard of care. PFS assessed by independent review committee was consistent. In addition, minimal residual disease (MRD)-negativity in peripheral blood at the end of combination treatment was 62.4% with Venclyxto plus MabThera compared to 13.3% with BR. Being MRD-negative means no cancer can be detected in the blood and or bone marrow using a sensitive test. In Europe, MRD is used as an indicator of a patient achieving longer endpoints such as PFS and overall survival. The most commonly observed side effects of Venclyxto plus MabThera included low white blood cell count (neutropenia), diarrhoea and upper respiratory tract infection.

Venclyxto was previously granted 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. Today’s EU approval follows the US Food and Drug Administration approval in June 2018 of Venclexta® in combination with Rituxan® for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Additional submissions of the MURANO data to health authorities around the world are ongoing.

Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, under the brand name Venclexta, and commercialised by AbbVie outside of the United States.
residual disease (MRD) and safety. AbbVie presents data on Venetoclax for the management of blood cancers.

Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Roche has also announced that the randomised phase III CLL14 study, which evaluated fixed-duration Venclexta®/Venclyxto® (venetoclax) in combination with Gazyva®/Gazyvaro® (obinutuzumab) in people with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions, met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death (PFS; as assessed by investigator) compared to standard-of-care Gazyva/Gazyvaro plus chlorambucil. The results showed that no new safety signals or increase in known toxicities of Venclexta/Venclyxto or Gazyva/Gazyvaro were observed with the treatment combination.

Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development 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.”