MHRA approves Novartis' Piqray for more advanced breast cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorization to extend the license in Great Britain for Swiss pharma giant Novartis’ (NOVN: VX) Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, 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.

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, noted Novartis. 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.

In July 2020, the European Medicines Agency 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.