AbbVie receives draft NICE guidance on VENCLYXTO®▼(venetoclax) plus rituximab for treating relapsed or refractory chronic lymphocytic leukaemia

MAIDENHEAD, Friday 26^th October 2018 – AbbVie today received the draft guidance from the National Institute for Health and Care Excellence (NICE) not recommending venetoclax plus rituximab for the treatment of relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) in adults.

Jérôme Bouyer, General Manager, AbbVie UK, said: “We are disappointed with the outcome of the draft decision, however this is not the final step in the appraisal and we are pleased NICE has recognised that venetoclax plus rituximab could be an important treatment option with an acceptable safety profile. We are also pleased to learn that patient experts would welcome a therapy with a fixed treatment duration in this setting. We remain committed to ensuring that patients with relapsed or refractory CLL have access to an important chemotherapy-free option.”

“Our priority now will be to work collaboratively with NICE to ensure they have all the necessary data to inform a robust evaluation and our aim remains to facilitate NHS access to venetoclax plus rituximab as quickly as possible via routine commissioning or the Cancer Drugs Fund (CDF).”

Over 3,500 people are diagnosed with CLL in the UK each year and the incidence has risen by 18% in less than 30 years.¹ For those patients living with CLL requiringtreatment, the majority will eventually have their disease recur.²

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For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

For the CHMP positive opinion for venetoclax in combination with rituximab, please visit:

https://www.ema.europa.eu/documents/smop/chmp-summary-positive-opinion-venclyxto-ii/08_en.pdf

▼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 uk_pvvendor@abbvie.com

For further information:

AbbVie UK Media:

Joanna Jones

07795590344

Joanna.jones@abbvie.com

Francesca Morley

07795360167

Francesca.Morely@virgohealth.com

Notes to editors

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.

About AbbVie

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References

¹ 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: October 2018

² American Cancer Society. (2013) Leukemia – Chronic Lymphocytic. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia.html. Accessed October 2018