Draft guidelines do not recommend NHS use of AbbVie’s Venclyxto for treating relapsed or refractory chronic lymphocytic leukaemia (CLL).

The National Institute for Health and Care Excellence said there were uncertainties with both the clinical evidence and the economic modeling provided.

Clinical trial evidence does suggest that Venclyxto (venetoclax) plus rituximab boosts progression free survival compared with bendamustine plus rituximab, but the latter combination is now “rarely used”, it noted.

Also, indirect comparisons of the regimen with the current standard of care, ibrutinib (AbbVie/Johnson & Johnson’s Imbruvica), “have limitations, so no firm conclusions can be drawn about the size of the benefit for venetoclax plus rituximab”.

Therefore, it was concluded that Venclyxto could not be recommended either for routine NHS use or for inclusion in the Cancer Drugs Fund.

“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,” said Jérôme Bouyer, general manager, AbbVie UK.

“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.”

He went on to say that the 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. For patients living with the disease and requiring treatment, the majority will eventually have their disease recur.

Venclyxto is a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein, restoring the body’s ability to trigger cancer cell self-destruction.