MHRA approves Piqray + fulvestrant for patients with PIK3CA mutation in HER +, HER2-breast cancer.
Resistance to endocrine therapy is a significant concern in the treatment of advanced breast cancer. PIK3CA mutations are a driver of developing endocrine resistance, which may lead to faster disease progression for patients, and a worse prognosis. Endocrine resistance affects approximately 40% of HR+/HER2- advanced breast cancer patients. There is a need for new therapies that are able to specifically target the PIK3CA mutation, therefore overcoming endocrine resistance; with the goal of improved efficacy with a manageable toxicity profile that may maintain quality of life.
Dr Marina Parton, consultant oncologist in Breast Cancer at The Royal Marsden explains, “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. 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.”
In July 2020, the European Medicines Agency (EMA) approved alpelisib for use in combination with fulvestrant for advanced breast cancer patients with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy. The EMA licence did not include patients that have received prior endocrine and CDK4/6 inhibitor combination treatment, therefore to ensure greater access for all eligible patients in Great Britain, Novartis decided to proceed with the national approval process and submitted to the MHRA for a broader licence.
In the UK, breast cancer is the most common type of cancer, with around 55,000 women diagnosed with breast cancer each year. Approximately 30% of women with earlier stages of breast cancer will develop advanced disease. Advanced breast cancer is an incurable disease, it is known that only 66% of women will survive for over a year or more and around 26.2% for five years when diagnosed at the latest stage.
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