NICE Recommends VENCLYXTO®▼(Venetoclax) Combination in Certain Patients with the Aggressive Blood Cancer Acute Myeloid Leukaemia (AML)

NICE Recommends VENCLYXTO^®▼(Venetoclax) Combination in Certain Patients with the Aggressive Blood Cancer Acute Myeloid Leukaemia (AML) 

­        Venetoclax in combination with azacitidine will be immediately available to

untreated adult patients with AML unable to receive intensive chemotherapy (IC) ¹

­        The combination has demonstrated ability to offer these patients significantly improved

overall survival, increased rates of rapid and durable remission and blood transfusion

independence, compared with treatment with azacitidine alone²

­        Clinical experts describe the combination as the greatest advance in 30 years³ for those

unable to receive IC for this aggressive, difficult-to-treat blood cancer, which has a low

survival rate⁴

Maidenhead, UK, 16 December 2021 – The National Institute for Health and Care Excellence (NICE) has today published a positive Final Appraisal Document recommending routine NHS use of VENCLYXTO^® (venetoclax) with azacitidine for the treatment of AML.¹ Venetoclax with azacitidine is recommended, within its marketing authorisation, as an option for untreated AML in adults when IC is unsuitable.¹ The decision means these patients will now benefit from a treatment offering significantly improved overall survival, increased rates of rapid and durable remission and blood transfusion independence, compared with treatment using azacitidine alone.^1,2

AML is an aggressive and difficult-to-treat blood cancer with a low survival rate.⁴ Approximately 3,200 people are diagnosed with AML in the UK every year, which equates to more than eight new cases every day. ⁵ The disease predominately affects older people and around 40% of those newly diagnosed are unable to tolerate the standard first-line treatment, IC, due to fitness or presence of other conditions. ^1,6 The past three decades have seen few advances in the treatment of AML. ⁷ With limited treatment options, the prognosis for these patients has remained poor. Median survival is just 6–10 months, during which patients typically require hospitalisation and frequent blood transfusions impacting their quality of life. ^8,9

Venetoclax is an oral once-daily treatment, which works by blocking the action of the B-cell lymphoma-2 (BCL-2) protein, the presence of which helps cancer cells survive. ¹⁰ As it can be taken at home and reduces dependency on blood transfusions, treatment with venetoclax was considered by patient and clinical experts to likely mean fewer hospital visits for these clinically vulnerable patients, who are more susceptible to coronavirus and other infections. ¹¹ 

Zack Pemberton-Whiteley, chief executive of Leukaemia Care, said ‘AML is a rapidly progressing, life-threatening disease, which has a significant emotional and practical burden on patients and their loved ones. Advances in treatment have been slow, especially for this group of patients. The availability of a new effective and more tolerable treatment, which can be administered largely at home, is very welcome news’. 

Commenting on the decision, Professor Charlie Craddock, academic director of the Centre for Clinical Haematology, Queen Elizabeth Hospital, Birmingham and professor of haemato-oncology, at the University of Birmingham: ‘Venetoclax plus azacitidine is the most important advance in the treatment of AML for patients not suitable for intensive chemotherapy in over 30 years and represents a step change in therapy for this common blood cancer’.

Belinda Byrne, medical director, AbbVie UK said, ‘This is a disease with an urgent need for effective new treatments. Routine availability within the NHS of the venetoclax with azacitidine combination will give patients back precious time with families and improve their quality of life. We are delighted with this recommendation from NICE and commend the committee for its robust and timely consideration of the evidence’.

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.