Scottish Medicines Consortium says yes to chemotherapy-free leukaemia treatment

The Scottish Medicines Consortium (SMC) has approved a new chemotherapy-free treatment option for some adults with untreated chronic lymphocytic leukaemia (CLL).

The approval follows a similar decision by the National Institute of Health and Care Excellence in November  and means that targeted treatment combo of venetoclax (Venclyxto) plus obinutuzumab (Gazyvaro) will now also be available on the NHS in Scotland. 

Targeted treatment combo

The new treatment option will be made available to people with untreated CLL for the first time in Scotland, as a fixed 12-month chemotherapy-free treatment. 

A type of blood cancer that affects white blood cells, CLL accounts for around 30% of all leukaemia cases in adults. People with CLL are typically offered different treatments depending on whether their leukaemia has certain genetic markers – such as a 17p deletion or a TP53 mutation – and how likely they are to tolerate combinations involving chemotherapy. 

For people with a 17p deletion or a TP53 mutation, CLL does not usually respond well to standard chemo-immunotherapy combinations, and the targeted drug ibrutinib (Imburvica) is usually used instead. 

Venetoclax plus obinutuzumab will now offer an additional option for these people, without the need for chemotherapy. 

The new treatment option will also be made available for patients with untreated CLL who don’t have these genetic markers, if other treatment options aren’t more suitable. 

Reducing side effects

Venetoclax plus obinutuzumab has not been directly compared to ibrutinib in people whose CLL has the genetic markers in clinical trials.  

Clinical trial results show that in people with CLL without a 17p deletion or TP53 mutation who can’t take chemo-immunotherapies, venetoclax plus obinutuzumab increased the time taken for the cancer to get worse compared to the chemo-immunotherapy combination of obinutuzumab and chlorambucil.

At an average follow up of 39.6 months, too few patients on the venetoclax plus obinutuzumab combo had seen their cancer get significantly worse to gather data on how long the combo can delay cancer progression. That’s compared to an average of 35.6 months before the cancer got significantly worse for patients being treated with chlorambucil and obinutuzumab.

Trials are currently ongoing to determine the clinical effectiveness of venetoclax plus obinutuzumab for people with untreated CLL without a genetic marker compared with existing chemo-immunotherapies. 

O’Neill said that for those who haven’t already had treatment for this type of leukaemia, this drug combination can now be used as an alternative initial treatment instead of chemotherapy. “Studies show that the chances of developing side-effects with this pair of drugs are less likely than with standard chemotherapy. 

“For those people that can receive this treatment, this means better quality of life and more opportunities to spend time doing the things they love. Targeted treatments like this will help us beat cancer sooner.”