EU Approves Novartis' Kisqali for Early Breast Cancer Treatment

The European Commission (EC) has recently approved Novartis' drug Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of early-stage breast cancer. This combination therapy is designed for patients with high-risk, hormone receptor-positive, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

This approval is based on the significant results from the global Phase III NATALEE trial, which assessed the safety and effectiveness of Kisqali combined with endocrine therapy, compared to endocrine therapy alone. The study involved 5,101 participants from 20 different countries. Findings from the trial indicated a 25.1% reduction in the risk of disease recurrence and demonstrated consistent invasive disease-free survival (iDFS) benefits across various patient subgroups. The primary measure of success for this study was iDFS, as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria.

The EC's approval follows a similar nod from the US Food and Drug Administration, which had also recently approved Kisqali for the same purpose. Additionally, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology has recommended Kisqali as a preferred adjuvant treatment for breast cancer, classifying it as a Category 1 option.

Novartis, in collaboration with Astex Pharmaceuticals, developed this therapy. Iris Zemzoum, president of Novartis Europe, commented on the approval, highlighting the persistent concern of breast cancer recurrence among patients. She emphasized the importance of providing treatment options that reduce the risk of cancer returning, thereby offering peace of mind to patients. Zemzoum expressed pride in this approval, noting that it addresses a significant unmet need and aims to enhance health outcomes for a larger group of patients in Europe.

In a recent business development, Novartis has also acquired Kate Therapeutics, a San Diego-based company, in a deal valued at $1.1 billion.