FDA Approves Kisqali Regimen for HR+/HER2- Early Breast Cancer

The FDA has approved Kisqali plus an aromatase inhibitor for patients with HR-positive, HER2-negative early breast cancer.

The Food and Drug Administration (FDA) has approved Kisqali (ribociclib) with an aromatase inhibitor for the postsurgical treatment of patients with hormone receptor (HR)-positive, HER2-negative stage 2 and 3 early breast cancer at a high risk of recurrence, the agency announced.

The agency also announced that it has approved a Kisqali and Femara (letrozole) co-pack for the same indication.

The efficacy of Kisqali with a non-steroidal aromatase inhibitor was demonstrated in the phase 3 NATALEE trial of 5,101 adult patients with HR-positive, HER2-negative early breast cancer. The trial included the participation of patients with any lymph node involvement, except for microscopic, or with no nodal involvement, tumor size of greater than 5 centimeters (cm) or 2 to 5 cm with grade 2 and high genomic risk or Ki67 ≥ 20% or grade 3 disease.

“The FDA approval of Kisqali for this early breast cancer population, including those with N0 disease [cancer that has not spread to the lymph nodes], is a pivotal moment in improving our approach to care,” said Dr. Dennis J. Slamon, Director of Clinical/Translational Research, UCLA Jonsson Comprehensive Cancer Center and Chairman of the Board of Translational Research In Oncology (TRIO) and NATALEE trial lead investigator in a news release issued by manufacturer Novartis. “Today’s approval allows us to offer treatment with a CDK4/6 inhibitor to a significantly broader group of people as a powerful tool that, combined with endocrine therapy, can help further minimize their risk of cancer returning.”

Patients received either 400 milligrams of Kisqali and NSAI or NSAI alone and could receive Zoladex (goserelin) as indicated.

Patients were evaluated for invasive disease-free survival (iDFS), defined as the time until the first occurrence of local or regional invasive disease recurrence in the breast, distant recurrence, death from any cause, contralateral invasive breast cancer or secondary primary non-breast invasive cancer, with the exception of basal and squamous cell carcinoma of the skin.

Results showed the iDFS at 36 months to be 90.7% in the Kisqali and NSAI arm and 87.6% in the NSAI arm.

The agency reported that side effects observed in the trial were consistent with the current safety profile for Kisqali with an NSAI. According to Novartis, side effects of special interest in the Kisqali arm of the NATALEE trial of all grades of severity and grades 3 (severe)/4 (life-threatening) included neutropenia (low level of neutrophils, a type of white blood cell, 62.5%, 44.3%), liver-related side effects (26.4%, 8.6%), QT interval prolongation (irregular heart rhythm, 5.3%, 1.0%) and interstitial lung disease (scarring of the lung tissue)/pneumonitis (inflammation of the lung tissue) (1.5%, 0.0%).

The recommended Kisqali dose post-surgery is 400 milligrams taken orally daily for 21 days followed by seven days off in 28-day treatment cycles.

In 2018, the FDA approved Kisqali plus an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, marking the first endocrine-based therapy for these patients.

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