The drug can now be used in combination with fulvestrant to treat hormone receptor positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation in men and postmenopausal women

breast cancer

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a licence extension for alpelisib (Piqray; Novartis), a phosphatidylinositol 3-kinase (PI3K) inhibitor. The licence extension allows the drug to be used in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy.

Taken orally, alpelisib blocks the PI3K pathway, which helps cells get the energy they need. If a mutation in the PIK3CA gene overactivates this pathway, cancer cells can survive and grow. By blocking this pathway, PI3K inhibitors help achieve the goal of killing cancer cells.

Significant development 

Dr Marina Parton, Consultant Oncologist in Breast Cancer at The Royal Marsden NHS Foundation Trust, said: ‘This approval is a significant development in advanced breast cancer, providing patients with additional treatment options, where there is much need for innovation that provides better clinical and patient outcomes.’

Cancer Research UK states that breast cancer is the most common cancer in the UK, with around 55,900 new cases diagnosed every year, equating to more than 150 new cases each day. Treatment of advanced breast cancer is associated with resistance to endocrine therapy, and around two in every five patients with HR+/HER2- advanced breast cancer are affected by this resistance. PIK3CA mutations are a driver of developing endocrine resistance, which may lead to faster disease progression, and a worse prognosis for those affected.

2019 study published in the New England Journal of Medicine concluded: ‘Treatment with alpelisib–fulvestrant prolonged progression-free survival among patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer who had received endocrine therapy previously.’

Improved quality of life 

Heather Moses, Country Medical Director at Novartis Oncology UK, emphasised how important it is to ‘identify new pathways or mutations, such as PIK3CA, that may play a role in disease progression, and identify and implement solutions for these patients with the aim of improving their quality of life.’

Dr Parton added: ‘Targeted therapies, such as alpelisib for HR+/HER2- advanced breast cancer with the PIK3CA mutation, are a step in the right direction to improve the standard of care and enable more eligible patients in Great Britain to gain access to the best possible treatments available.’

This article originally appeared on Medscape, part of the Medscape Professional Network.


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