Novartis Pharmaceuticals UK Ltd.

Novartis’ Kisqali (ribociclib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a broad population of early breast cancer patients. The UK regulator has approved the drug for use in combination with an aromatase inhibitor as an adjuvant treatment for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. The marketing authorisation also outlines that, in pre- or perimenopausal patients, the aromatase inhibitor should be given alongside a luteinising hormone-releasing hormone agonist. Approximately 55,000 people are diagnosed with breast cancer every year in the UK, and HR-positive/HER2-negative is the most common subtype. Despite current treatment options, patients with HR-positive/HER2-negative early breast cancer remain at risk of experiencing disease recurrence in the long term, often as incurable disease. Novartis’ Kisqali is designed to inhibit the CDK4/6 proteins which, when over-activated, can enable cancer cells to grow and divide too quickly, and is already approved in the UK for certain cases of advanced breast cancer. The MHRA’s latest decision on the drug was supported by positive results from the late-stage NATALEE trial, in which the Kisqali combination reduced invasive disease-free survival events by 25.1% compared to treatment with an aromatase inhibitor alone. Gerrit Zijlstra, chief medical officer for the UK and Ireland at Novartis, said: “With consistent results across patient subgroups, [Kisqali] is now licenced for a broad population of patients diagnosed with HR-positive/HER2-negative early breast cancer at high risk of recurrence. “The MHRA decision builds on the confidence established by the NATALEE trial and highlights the potential of [Kisqali] to reduce the risk of recurrence in early breast cancer, addressing a significant unmet need for patients in the UK.” The National Institute for Health and Care Excellence and Scottish Medicines Consortium will now determine whether Kisqali in this indication will be reimbursed for use on the NHS. Stephen Johnston, professor of breast cancer medicine, consultant medical oncologist, and head of the breast unit at the Royal Marsden NHS Foundation Trust, said: “The possibility of breast cancer returning can be a continuous concern for people who have been diagnosed with the disease… The introduction of [Kisqali] as a treatment option for early-stage breast cancer to reduce the risk of recurrence is a promising development for both clinicians and patients…”