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Swiss multinational pharmaceutical corporation Novartis has announced the approval by US Food and Drug Administration (FDA) of their brand of ribociclib (Kisqali®) for the adjuvant treatment of stage II and III early breast cancer (EBC).

Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). 

It is taken as a once-daily oral dose of 400 mg for three weeks, followed by one week off treatment, in combination with four weeks of any AI. It is recommended that patients should take Kisqali for three years. 

The drug, authorized in combination with an aromatase inhibitor (AI), will specifically be used in patients suffering from hormone receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) EBC having a high risk of recurrence, including those with node negative (NO) disease.

"The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease, is a pivotal moment in improving our approach to care," stated Dennis J. Slamon, M.D., Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center.

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According to Novartis, the approval decision was based on "significant and clinically meaningful" Phase III data derived from the clinical trial coded NATALEE.

NATALEE is a worldwide Phase III multi-center, randomized, open-label trial to evaluate the safety and efficacy of Kisqali® (ribociclib) with endocrine therapy (ET) as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2-EBC, being conducted in collaboration with Translational Research in Oncology. 

A total of 5,101 adult patients with HR+/HER2-EBC across 20 countries were randomized in the trial.

The results of this study showed a 25.1% decrease in risk of disease recurrence in a population of patients with HR+/HER2-stage II and III EBC treated with adjuvant Kisqali in combination with endocrine therapy (ET) in comparison to ET alone, including those with high-risk N0 disease.

Victor Bultó, President of US, Novartis reiterated their commitment in the fight against cancer: "We continue to transform cancer care with Kisqali, building on its established profile in the metastatic setting and now helping a wide range of people as they strive to stay cancer-free following an early-stage diagnosis."

Some of the noted adverse events (AEs) in the Kisqali plus endocrine therapy arm of the NATALEE trial include neutropenia, liver-related AEs, QT interval prolongation, and interstitial lung disease/pneumonitis.

Kisqali, a product developed by Novartis through a research collaboration with Astex Pharmaceuticals, has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide.

Additionally, assessment for Kisqali as an early breast cancer treatment is in process in the European Union and China.

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