New drugs approved in 2024 and what’s coming up in 2025

Making sure that new and effective breast cancer drugs quickly reach patients on the NHS is a key priority for us. That’s why we're involved in the process whenever a breast cancer drug is being assessed for use on the NHS, making sure the voices of people affected by breast cancer are heard loud and clear throughout.

In England, the National Institute for Health and Care Excellence (NICE) is the organisation that decides which new medicines will be available on the NHS. Wales and Northern Ireland normally follow NICE guidance. In Scotland, the Scottish Medicines Consortium (SMC) decides which new medicines will be available on the NHS in Scotland. 

This blog post looks at some key decisions for 2024, and what drug decisions may be coming up later this year.

In February, NICE approved talazoparib for use on the NHS in England for those with secondary breast cancer, and the SMC followed suit in Scotland in March. Talazoparib is used to treat HER2-negative advanced breast cancer with germline BRCA mutations.

Talazoparib is a PARP inhibitor, which Breast Cancer Now helped discover through its research. 

In October, the National Cancer Medicines Advisory Group supported the use of anastrazole, raloxifene and tamoxifen as risk reducing treatments for breast cancer in Scotland. 

However, we are concerned that there isn’t currently a national pathway to access these treatments. If you have had any issues accessing these treatments, please get in touch with us at policy@breastcancernow.org

In December, NICE approved elacestrant (Korsedu) for treating oestrogen receptor-positive, HER2-negative advanced breast cancer with an ESR1 mutation after endocrine treatment in England. 

Elacestrant is the first targeted treatment for this specific gene mutation, which is often associated with faster disease progression and worse survival, so this decision is extremely welcome.

We expect elascestrant to be considered by the SMC later in 2025.

Unfortunately, 2024 also saw the devastating rejection of trastuzumab deruxtecan (Enhertu) for HER2-low unresectable or metastatic breast cancer after chemotherapy in England. 

Despite over 300,000 people signing our #EnhertuEmergency petition, the incredible campaigning of women living with HER2-low secondary breast cancer, and the direct intervention of Health Secretary Wes Streeting, drug companies AstraZeneca and Daiichi Sankyo failed to agree a deal with NHS England that would make the drug available for those who needed it.

The decision was a huge injustice. We think that wider issues in the NICE drug appraisal system had a big impact on this decision, so we’re looking at what needs to change to ensure that people living with secondary breast cancer are not denied access to similar game changing treatments in the future.

Drug appraisal timings can often change, but some of the drugs NICE and the SMC are considering in 2025 include:

We’ve already started the new year with some positive news after olaparib (Lynparza) was approved for treating BRCA mutation-positive HER2-negative secondary breast cancer after chemotherapy in England.

It was approved through a cost-comparison appraisal thanks to its similarity to already approved talazoparib. 

Olaparib was also just approved for use on NHS Scotland by the SMC. This means olaparib is now available across the whole of the UK, for eligible secondary breast cancer patients to provide a valuable choice for both patients and clinicians.  

Sadly however, 2025 has also seen the provisional rejection of capivasertib (Truqap) with fulvestrant (Faslodex) in England for treating HR-positive, HER2-negative advanced breast cancer after endocrine treatment. 

The drug was rejected due to uncertainties in the evidence, but we hope that NICE and drugs manufacturer AstraZeneca will address these soon so the treatment can be approved as quickly as possible. 

We expect that capivasertib will also be considered by the SMC in Scotland later this year. 

In spring NICE will consider the use of ribociclib (Kisqali) with an aromatase inhibitor for the adjuvant treatment of HR-positive, HER2-negative early breast cancer. 

This would be the second CDK 4/6 inhibitor considered for primary breast cancer after abemaclib (Verzenios). These treatments are already widely used as a first line treatment for those with secondary breast cancer.

NICE will be assessing trastuzumab deruxtecan (Enhertu) for HER2-positive secondary breast cancer after 1 or more anti-HER2 treatments. 

Enhertu has been available for this group of patients through the cancer drugs fund since 2023, allowing NICE and the pharmaceutical companies to collect more data on its effectiveness. The appraisal will consider whether it should be made routinely available on the NHS.
This decision will affect a different group of patients to the ones we campaigned for in our #EnhertuEmergency campaign. 

We’re interested to hear from anyone with HER2-positive secondary breast cancer who has received Enhertu so that we can share their experiences with NICE as part of this appraisal. If you’d like to share your story, please contact us at policy@breastcancernow.org.

We also expect to see appraisals for new secondary breast cancer drugs inavolisib, imlunestrant and dotopotomab deruxtecan starting in 2025, so will be keeping an eye out for these over the coming months.