14 July 2022

Responding, Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:

“It’s absolutely fantastic news that following a provisional rejection in March, alpelisib with fulvestrant has now been recommended by NICE for routine use on the NHS, bringing hope to thousands of patients living with a particular type of incurable secondary breast cancer*

“This will be the first targeted treatment option available for certain patients with a PIK3CAmutation which is estimated to be found in around 30-40% of oestrogen receptor positive, HER2 negative breast cancers. Importantly, clinical evidence suggests that alpelisib with fulvestrant is more effective than the current standard treatment option – everolimus with exemestane – and is another step in delaying chemotherapy for patients, which can be associated with grueling side effects.

“Today also marks the long-awaited approval of life-extending drug, Trodelvy, for certain women living with incurable triple negative secondary breast cancer, following ten agonising months since the drug was licensed by the MHRA. Far too often, breast cancer drugs are receiving initial provisional rejections for use on the NHS and requiring multiple committee meetings, and there is urgent work to be done to ensure positive outcomes are reached far quicker for people living with breast cancer.

“NICE, NHS England and the pharmaceutical industry all have a pivotal role to play in reducing avoidable delays for patients accessing new, effective treatments, and Breast Cancer Now continues to be committed to playing a lead role in ensuring this happens for the benefit of breast cancer patients now and in the future.

“Anyone seeking information and support can speak to our expert nurses by calling our free Helpline on 0808 800 6000.”




* For patients with hormone receptor positive, HER2 negative, PIK3CA mutated locally advanced or secondary (metastatic) breast cancer after a CDK 4/6 inhibitor plus aromatase inhibitor

*Whilst Northern Ireland normally follows NICE guidance, the marketing authorisation (also known as licence) from the Medicines and Healthcare products Regulatory Agency (MHRA) applies to Great Britain only and the current European Medicines Agency (EMA) marketing authorisation differs and does not include patients that have received a CDK 4/6 inhibitor with an aromatase inhibitor which is the standard of care across the UK. We hope that Novartis will seek a broader licence through the EMA, to ensure all eligible patients across the UK can access alpelisib with fulvestrant once their cancer has progressed after a CDK 4/6 inhibitor plus an aromatase inhibitor