MHRA approves license extension for Novartis’ breast cancer targeted therapy

pharmafile | December 24, 2021 | News story | Medical Communications  

The MHRA has approved the marketing authorisation to extend Novartis’ licence in Great Britain for Piqray (alpelisib), for use in combination with fulvestrant, for the treatment of advanced breast cancer patients with a PIK3CA mutation following disease progression.

Piqray will be used 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.

PIK3CA mutations are a driver of developing endocrine resistance, which may lead to faster disease progression for patients, and a worse prognosis. Resistance to endocrine therapy is a significant concern in the treatment of advanced breast cancer, and it affects approximately 40% of HR+/HER2-advanced breast cancer patients.

This highlights the growing need for new therapies which specifically target the PIK3CA mutation.

Dr Marina Parton, consultant oncologist in Breast Cancer at The Royal Marsden 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. 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.”

Heather Moses, Country Medical Director at Novartis Oncology UK says, “An advanced breast cancer diagnosis is devastating for patients, their families and their loved ones, which is why it is our priority to reimagine how we deliver care for these people. We wanted to ensure that all eligible patients in Great Britain have access to this treatment option by securing a broader licence through the MHRA. This marketing authorisation not only demonstrates our bold patient-first approach and ongoing commitment to the breast cancer community, but continued alignment to the priorities for the NHS in its Long-Term Plan for cancer patients.

Despite the challenges of the COVID-19 pandemic, we have continued to partner with the NHS and the entire health ecosystem in order 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.”

Lina Adams

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