NEW YORK – The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor as a treatment for patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer who are at high risk for recurrence.
The MHRA clarified that pre- or perimenopausal women, or men, should receive the aromatase inhibitor with a luteinizing hormone-releasing hormone (LHRH) agonist.
Previously, the MHRA had approved Kisqali for advanced breast cancer patients.
The regulator made its decision to approve Kisqali with an aromatase inhibitor in the early-stage breast cancer setting after reviewing data from the NATALEE trial, comparing the regimen against treatment with just an aromatase inhibitor. The Phase III study enrolled pre- and postmenopausal women and men with HR-positive, HER2-negative tumors if their disease was at high risk of recurrence based on several factors: if the cancer had spread to the lymph nodes; if the tumor was bigger than 5 cm; or if the tumor was between 2 and 5 cm and also classified as either grade 2 with a high genomic risk or a Ki67 score of at least 20 percent or grade 3.
Treatment with Kisqali alongside an aromatase inhibitor reduced invasive disease-free survival events by around 25 percent versus an aromatase inhibitor alone. Invasive disease-free survival at three years was 91 percent on the Kisqali-aromatase inhibitor combination and 88 percent with just an aromatase inhibitor.
Last year, the US Food and Drug Administration approved Kisqali with an aromatase inhibitor in this early-stage breast cancer setting based on this same data, and the European Medicines Agency's Committee for Medicinal Products for Human Use also recommended approval for this indication.
Novartis is still analyzing data in the NATALEE study and tracking overall survival events. "The MHRA decision builds on the confidence established by the NATALEE trial and highlights the potential of ribociclib to reduce the risk of recurrence in [early breast cancer], addressing a significant unmet need for patients in the UK," Gerrit Zijlstra, chief medical officer for the UK and Ireland at Novartis, said in a statement.