The FDA granted approval for ribociclib (Kisqali) in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. The approval also included the Kisqali Femara Co-Pack, which combines ribociclib with letrozole.
Ribociclib combination improved early breast cancer outcomes, with 3-year invasive disease-free survival reaching 90.7% in high-risk patients.
The decision was based on results from the NATALEE trial (NCT03701334), a randomized, open-label, multicenter study involving 5,101 adults. The trial included patients with any lymph node involvement (excluding microscopic nodal involvement), or if there was no nodal involvement, either a tumor size greater than 5 cm or a tumor size 2 to 5 cm with either Grade 2 (and high genomic risk or Ki67 ≥ 20%) or Grade 3.
Participants were randomized (1:1) to receive ribociclib (400 mg) plus non-steroidal aromatase inhibitor (NSAI) or NSAI alone. Randomization was stratified by anatomic stage, prior chemotherapy (neoadjuvant versus adjuvant), menopausal status (premenopausal and males versus postmenopausal), and region (North America/Western Europe/Oceania versus rest of the world).
The trial demonstrated a statistically significant improvement in invasive disease-free survival (iDFS) for patients receiving ribociclib with an NSAI compared to those receiving NSAI alone. iDFS was defined as randomization to the first occurrence of local or regional invasive breast recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, or secondary primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin).
The recommended dosage for ribociclib in the adjuvant setting is 400 mg taken orally once daily for 21 consecutive days, followed by 7 days off, in 28-day treatment cycles. This regimen is to be used in conjunction with an aromatase inhibitor.
Adverse reactions observed in the NATALEE trial were consistent with the known safety profile of ribociclib combined with an NSAI. Health care providers should refer to the full prescribing information for detailed safety data.
Kisqali requires refrigeration until dispensed to patients. After dispensing, patients should store the medication at room temperature for up to 2 months.
The FDA's review process utilized the Assessment Aid, a voluntary submission from the applicant designed to facilitate the agency's assessment.
Healthcare professionals should report all serious adverse events suspected to be associated with using any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, health care professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.
This approval expands treatment options for patients with high-risk early breast cancer.
Reference:
U.S. Food and Drug Administration. FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-kisqali-aromatase-inhibitor-and-kisqali-femara-co-pack-early-high-risk-breast-cancer