Scottish Medicines Consortium approves breast cancer drug abemaciclib for use in combination with fulvestrant AND in combination with an aromatase inhibitor 

Monday 13 May 2019      Scotland
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The Scottish Medicines Consortium (SMC) has today (13 May 2019) announced its decision to approve breast cancer drug abemaciclib as part of two new treatment options for routine use on Scotland’s NHS. 

Abemaciclib (Verzenios, Lilly UK) is one of a new class of drugs known as CDK4/6 inhibitors, which work by targeting two crucial cell division proteins called CDK4 and CDK6. 

The SMC has today approved:

•    Abemaciclib in combination with fulvestrant for certain patients with hormone positive, HER2 negative locally-advanced or metastatic breast cancer who have received prior hormone therapy. The manufacturer estimates that around 490 patients in Scotland each year will now be eligible to receive abemaciclib with fulvestrant.

•    Abemaciclib in combination with an aromatase inhibitor as an alternative first-line treatment option for newly-diagnosed patients with hormone positive, HER2 negative locally-advanced or metastatic breast cancer. Other similar drugs palbociclib and ribociclib have already been approved by the SMC for use in combination with an aromatase inhibitor in treating this patient group, and today’s decision will see a third option made available to patients1 and their doctors.

For patients who have received prior hormone therapy, a major trial (MONARCH 2) has shown that giving abemaciclib with fulvestrant extends the time before a patient’s disease progresses (progression free survival) by 7.1 months on average, compared to fulvestrant alone. Overall survival data from the trial is not mature, so it is not yet known whether the progression-free extension may also translate into life extension.

Ashleigh Simpson, Policy and Campaigns Manager (Scotland) at Breast Cancer Care and Breast Cancer Now, said: 

We’re delighted that abemaciclib has been approved as part of two new combination treatments that could benefit hundreds of breast cancer patients in Scotland. 

The approval of abemaciclib with fulvestrant is particularly exciting as it will enable certain women who have received prior hormone therapy to finally benefit from innovative CDK 4/6 inhibitors. Until now these treatments had only been available to newly-diagnosed patients [with locally-advanced or metastatic breast cancer].  

Crucially, this new combination [abemaciclib with fulvestrant] can give patients significant extra time before their disease progresses – time to live well that would be truly invaluable to them and their loved ones.  This new option could also help delay the need for chemotherapy and its gruelling side-effects, which will be highly-valued by patients. 

It is also fantastic that abemaciclib will be available for use in combination with an aromatase inhibitor as an alternative first-line option. Abemaciclib has been shown to be just as effective as palbociclib and ribociclib, but it can come with slightly different side effects. The routine availability of abemaciclib with an aromatase inhibitor will now help to improve patient choice, giving women more control over their quality of life
 

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