NICE gives green light for chemotherapy-free combination, Venclyxto® (venetoclax) plus obinutuzumab for all front-line patients with chronic lymphocytic leukaemia – the UK’s most common chronic blood cancer

NICE gives green light for chemotherapy-free combination, Venclyxto®   (venetoclax) plus obinutuzumab for all front-line patients with chronic lymphocytic leukaemia – the UK’s most common chronic blood cancer

• Positive recommendation for Venclyxto (venetoclax) means that all previously untreated patients with chronic lymphocytic leukaemia (CLL) will, for the first time, have a chemotherapy-free, fixed-duration treatment option¹
• NICE approval is based on data from Phase III CLL14 trial, which showed that patients treated with 1 year of treatment with venetoclax plus obinutuzumab had superior progression-free survival and sustained that benefit after stopping treatment compared with those receiving a commonly used chemoimmunotherapy regimen of obinutuzumab and chlorambucil²
• CLL is the most common form of chronic leukaemia (blood cancer) in adults, with approximately 3,800 new cases in the UK each year^3,4

Maidenhead, UK, 10 November, 2020 – AbbVie (NYSE: ABBV) announced, from today and for the first time, people with chronic lymphocytic leukaemia (CLL) who have not received any prior treatment will now have access to a chemotherapy-free, 12-month fixed-duration treatment that has been demonstrated to improve outcomes, allowing patients to live significantly longer without their disease progressing, compared to those receiving a commonly used chemoimmunotherapy.²

New guidance, published by The National Institute of Health and Care Excellence (NICE), recommends AbbVie’s venetoclax in combination with obinutuzumab for routine National Healthcare Service (NHS) use in patients with del(17p)/TP53 mutation and those without del(17p)/TP53 mutation for whom fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR) are unsuitable. In addition, NICE has also recommended the venetoclax combination for use within the Cancer Drugs Fund (CDF) for patients without del(17p)/TP53 mutation and for whom FCR or BR are suitable, subject to a managed access agreement.¹ The combination therapy will be available to NHS patients in England immediately.

CLL is the most common type of chronic blood cancer, with around 10 new patients diagnosed every day.^3,4 Unlike some cancers, CLL has a highly variable clinical course so patients are usually left to ‘watch and wait’, after which some patients will be offered appropriate treatment.⁵ However, despite novel therapeutic advancements in CLL, the disease remains incurable and patients will often relapse following treatment.⁶

Professor Peter Hillmen, consultant in clinical haematology at Leeds Teaching Hospitals and honorary professor of haematology at University of Leeds, commented: “Today’s announcement means that healthcare professionals will now have the option to prescribe a first-line, chemotherapy-free, 1-year fixed duration treatment option for all patients with CLL, that can produce a deep response, thus allowing patients to stop treatment and achieve sustained progression-free survival post-treatment cessation. Ultimately, this has the potential to improve patients’ quality of life and reduce the significant burden of therapy.”

Marc Auckland, CLL patient and chair of the CLL Support Association, said: “NICE’s recommendation signifies an important evolution in the CLL treatment landscape. Simply put, what we have here is a novel treatment which provides very deep response rates with a fixed duration of treatment – this a welcome milestone for the CLL community.”

Belinda Byrne, medical director at AbbVie UK, added: “As a company, our mission is to have a remarkable impact on people's lives – and we know we cannot go it alone. We have worked closely with NICE, NHS England and the clinical and patient community to ensure all CLL patients have access to venetoclax in the frontline setting as quickly as possible. This decision recognises the benefit of venetoclax for both CLL patients and the NHS.”

The European Commission approved venetoclax plus obinutuzumab for the treatment of for adult patients with previously untreated chronic lymphocytic leukaemia in March 2020.⁷

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.