FDA has approved Novartis Kisqali® (ribociclib), in combination with an aromatase inhibitor (AI), for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.
The approval is based on results from the pivotal phase III NATALEE trial, offering hope to patients with HR+/HER2- breast cancer.
Dennis J. Slamon, M.D., Director of Clinical/Translational Research at UCLA, acknowledged the FDA’s approval of Kisqali® for early breast cancer as a significant milestone.
He emphasized that Kisqali® approval expanded CDK4/6 inhibitor use to more patients, reducing cancer recurrence risk.
Victor Bultó, President, US, Novartis, acknowledged the FDA’s approval of Kisqali® for early-stage breast cancer and emphasized its expanded role in reducing recurrence risk, benefiting a broader population beyond metastatic settings.
Valarie Worthy, Co-Founder & VP of Community Outreach at Touch, The Black Breast Cancer Alliance, emphasized the significant toll of breast cancer treatment and the varied risk of recurrence.
She acknowledged the FDA’s approval of Kisqali® for more patients as a crucial step in helping manage the risk of cancer returning.
Source: FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer
https://www.novartis.com/news/media-releases/fda-approves-novartis-kisqali-reduce-risk-recurrence-people-hrher2-early-breast-cancer
