MHRA Approves Novartis' Kisqali for Early Breast Cancer Treatment

Novartis' Kisqali (ribociclib) has gained approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of a wide range of early breast cancer patients. This approval pertains to the drug's use in combination with an aromatase inhibitor, serving as an adjuvant therapy for individuals with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer who face a high risk of recurrence. For patients who are pre- or perimenopausal, the treatment protocol specifies that the aromatase inhibitor should be administered alongside a luteinising hormone-releasing hormone agonist.

In the UK, approximately 55,000 women receive a breast cancer diagnosis annually, with HR-positive/HER2-negative being the most frequently occurring subtype. Despite the availability of various treatment options, patients with HR-positive/HER2-negative early breast cancer still face a risk of disease recurrence over time, which can often result in an incurable condition. Kisqali is specifically designed to inhibit CDK4/6 proteins. These proteins, when excessively activated, can lead to rapid cancer cell growth and division. Previously, Kisqali had already been approved in the UK for treating certain advanced breast cancer cases.

The recent approval from the MHRA is backed by encouraging results from the NATALEE trial, a late-stage study. In this trial, the combination treatment involving Kisqali resulted in a 25.1% reduction in invasive disease-free survival events compared to treatment with only an aromatase inhibitor. Gerrit Zijlstra, the chief medical officer for the UK and Ireland at Novartis, emphasized the importance of these findings. He noted that with consistent results across various patient subgroups, Kisqali is now authorized for a broad spectrum of patients diagnosed with HR-positive/HER2-negative early breast cancer who are at high risk of recurrence. Zijlstra asserted that the MHRA's decision strengthens the confidence established by the NATALEE trial and underscores Kisqali's potential to mitigate the risk of recurrence in early breast cancer, thereby addressing a significant unmet need for patients in the UK.

Going forward, the responsibility falls to the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium to decide on the reimbursement status of Kisqali for this indication under the National Health Service (NHS). Stephen Johnston, a professor of breast cancer medicine and a consultant medical oncologist who heads the breast unit at the Royal Marsden NHS Foundation Trust, commented on the development. He remarked that the possibility of breast cancer recurrence is a persistent concern for those diagnosed with the disease. Johnston considers the introduction of Kisqali as a treatment option for early-stage breast cancer, aimed at reducing recurrence risk, to be a promising advancement for both healthcare professionals and patients alike.

This approval marks a significant step forward in breast cancer treatment, potentially offering a new avenue for reducing recurrence in a patient population that has long faced challenges despite existing therapeutic options. Novartis' Kisqali could represent a crucial development in improving long-term patient outcomes, aligning with the broader goal of enhancing the quality of life and prognosis for those affected by this prevalent form of cancer.