(Health Korea News / Yu Ji-in) On the 17th (local time), the U.S. Food and Drug Administration (FDA) approved Novartis’ ‘Kisqali (ingredient name: ribociclib)’ as an adjuvant treatment for patients with early-stage breast cancer (EBC). This is expected to expand the group of breast cancer patients for whom Kisqali can be prescribed.
Kisqali is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor. Kisqali is approved for the adjuvant treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) Stage II and III EBC at high risk for relapse, particularly those with node-negative (N0) disease.
This FDA approval is based on the results of the pivotal Phase 3 NATALEE trial, which demonstrated that adjuvant Kisqali plus ET reduced the risk of disease recurrence by 25.1% (HR=0.749; 95% CI: 0.628, 0.892; P=0.0006) compared to ET alone in patients with HR+·HER2- Stage II and III EBC. The benefit in invasive disease-free survival (iDFS) was consistent across all patient subgroups.
The FDA first approved Kisqali in combination with an aromatase inhibitor for postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer in March 2017. The following year, the indication was expanded to include patients with HR+, HER2- advanced or metastatic breast cancer, regardless of menopausal status.
The FDA has also approved Kisqali plus fulvestrant as first- and second-line treatment for postmenopausal women with advanced breast cancer.
Novartis presented data from the NATALEE trial of Kisqali plus endocrine therapy (aromatase) at the annual meeting of the European Society of Medical Oncology (ESMO) on the 13th. According to the ESMO analysis, the combination therapy reduced the risk of relapse by 28.5% after three years of treatment compared to aromatase alone.
Meanwhile, Kisqali’s main competitor is Eli Lilly’s CDK4·6 inhibitor Verzenio (generic name abemaciclib), which is approved for the same breast cancer indication as Kisqali, but differs from Kisqali in that its use is restricted to patients with lymph node metastases. Verzenio was the first CDK4·6 inhibitor approved as adjuvant therapy for HR+·HER2- early breast cancer in 2021.
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