- Positive recommendation for VENCLYXTO (venetoclax) in final appraisal determination (FAD) means that, for the first time, people in England with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a chemotherapy-free option with a fixed treatment duration of 24 months.
- NICE approval is based on the MURANO Phase 3 clinical trial, in which venetoclax plus rituximab (VenR) reduced the risk of disease progression or death by eighty-three percent compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).1
- Over 3,500 people in the UK are diagnosed with CLL every year, the most common type of blood cancer.2,3
MAIDENHEAD, 18th January, 2019– AbbVie today announces that the National Institute for Health and Care Excellence (NICE) has published a positive final appraisal determination (FAD) recommending that VENCLYXTO® (venetoclax) in combination with rituximab (VenR) is made available for routine use by the National Health Service (NHS) in England for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL) who have received at least one prior therapy. Please see the NICE website for the eligibility criteria here.
David Innes, Chair of the CLL Support Association said: “The decision by NICE is extremely positive news for people living with relapsed or refractory CLL in England and has the potential to change the way we treat the disease. For many, a relapsed or refractory diagnosis can be daunting as when the disease comes back or progresses, prognosis can be poor. So to have NHS access to an effective chemotherapy-free option that is supported by robust clinical data and which patients do not have to take continuously is a welcome step forward. Patients will now have the chance to live longer with the added prospect of a treatment-free period.”
CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,4 Over 3,500 people are diagnosed with CLL in the UK each year.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur.5
Professor Peter Hillmen, Consultant Haematologist, Leeds Teaching Hospitals NHS Trust and Coordinating Investigator of venetoclax studies in the UK, said: “NICE’s decision to recommend routine NHS access to venetoclax plus rituximab in the relapsed/refractory CLL setting now gives treating clinicians a new weapon in the fight against CLL. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. The demonstration of improved survival outcomes after cessation of therapy signals an important move to defined duration of targeted therapy. The cessation of therapy is a key advance in the treatment of CLL.”
The NICE recommendation is based on results from the pivotal phase 3 MURANO clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared with a standard of care chemoimmunotherapy regimen of bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature).1
In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-) was a secondary endpoint. At the nine-month time point, sixty-two percent (n=121/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus thirteen percent (n=26/195) who received bendamustine plus rituximab.1 Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.6
Recent post treatment follow-up data has provided evidence on long terms outcomes for VenR. Of the 130 patients who completed rituximab plus the 24 month fixed duration of venetoclax, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively.7
Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to delivering breakthrough therapeutic options in CLL, an area where more treatments are urgently needed for patients. We have worked closely with NICE and the clinical and patient communities to ensure the timely appraisal of venetoclax plus rituximab in a concerted effort to bring much needed options to patients as quickly as possible. Alongside this, we have worked collaboratively with NHS England so that patients can access venetoclax plus rituximab without delay. We welcome this decision by NICE, and remain committed to improving patient outcomes in blood cancer.”
The European Commission approved venetoclax plus rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia who have received at least one prior therapy on 1st November 2018.8
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.
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The final NICE guidance can be accessed here: https://www.nice.org.uk/guidance/gid-ta10160/documents/final-appraisal-determination-document
For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.
▼Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact firstname.lastname@example.org
For further information:
AbbVie UK Media:
Notes to editors
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.9 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.9
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types.
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1 Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.
2 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: January 2019.
3 Cancer Research UK. Chronic lymphocytic leukaemia (CLL): Risks and causes. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/risks-causes Accessed: January 2019.
4 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: January 2019.
5 National Cancer Institute. Living as a Chronic Lymphocytic Leukemia Survivor. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/after-treatment/follow-up.html. Accessed: January 2019.
6 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018; 131(25):2745-2760.
7 Seymour J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.
8 AbbVie News Centre. AbbVie receives European Commission Approval of Venetoclax Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy. Available at: https://news.abbvie.com/news/press-releases/abbvie-receives-european-commission-approval-venclyxto-venetoclax-plus-rituximab-for-treatment-patients-with-chronic-lymphocytic-leukemia-who-have-received-at-least-one-prior-therapy.htm. Accessed January 2019.
9 Venclyxto Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/32650. Accessed January 2019.