A new treatment option for people with chronic lymphocytic leukaemia
United Kingdom
Today, (Tuesday 7 January), the drug regulators NICE have approved venetoclax (Venclyxto®) with obinutuzumab for use on the NHS in England.
This decision means that more people with chronic lymphocytic leukaemia (CLL) can now access this treatment earlier, when they are first diagnosed and need treatment.
CLL is a slow-growing blood cancer. Many people live with it for years, but when treatment is needed, the choice of drugs can make a big difference to how long treatment lasts and how it affects daily life.
What has been approved
Venetoclax with obinutuzumab is now approved for adults with previously untreated CLL who:
- do not have a 17p deletion or TP53 mutation, and
- standard chemo-immunotherapy options such as FCR (fludarabine, cyclophosphamide, rituximab) or BR (bendamustine, rituximab) are suitable
Why this approval matters
Venetoclax works differently from traditional chemotherapy. It targets a protein that helps cancer cells survive, encouraging those cells to die while leaving healthy cells less affected.
For many patients, venetoclax with obinutuzumab is given for a fixed period of time, rather than continuously.
Clinical studies have shown that this combination can control CLL effectively, helping people stay well for longer without ongoing therapy.
What did our expert say
Tracey Loftis, Deputy Director of Policy and Influencing from Blood Cancer UK, said:
“This decision from NICE gives more people with chronic lymphocytic leukaemia access to a time-limited, targeted treatment option on the NHS. This drug combination can include fewer long-term side effects and less time spent on treatment . This approval reflects the growing role of precision medicines in the treatment of blood cancer. At Blood Cancer UK we will continue to work with researchers, clinicians and people affected by blood cancer to push for faster access across all regions in the UK to the best possible treatments.”
What happens next and is this drug approved across the UK?
Health boards in England have 90 days to make this medicine available to patients. Wales and Northern Ireland usually follow NICE’s recommendation and make this available, but this can take longer than in England.
In Scotland, there is a separate approval process for medicines. In 2022, NHS Scotland approved Venetoclax for restricted use in combination with obinutuzumab in patients who have not been previously treated for their CLL; and who do not have a del(17p)/TP53 mutation; and who are fit enough to receive the chemo-immunotherapy FCR (fludarabine, cyclophosphamide and rituximab).