FDA approves Kisqali with an aromatase inhibitor and Kisqali Femara Co-Pack for early high-risk breast cancer
Regulatory approval: On Sept 17, 2024, the FDA approved ribociclib (Kisqali) with an aromatase inhibitor, and the Kisqali Femara Co-Pack (ribociclib + letrozole), for adjuvant treatment of adults with HR-positive, HER2-negative stage II–III early breast cancer at high risk of recurrence. Approval was supported by the phase 3 NATALEE trial, which showed improved invasive disease-free survival versus a non-steroidal aromatase inhibitor alone; overall survival was immature at final iDFS analysis.
FDA approval (Sept 17, 2024)
The FDA approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for adjuvant treatment of adults with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The agency also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack) for the same indication.
Supporting evidence: NATALEE (NCT03701334)
Efficacy and safety were evaluated in NATALEE, a randomized, open-label, multicenter trial (n=5101) in adults with HR-positive, HER2-negative early breast cancer. Key eligibility included any lymph node involvement (excluding microscopic nodal involvement), or node-negative disease with tumor size >5 cm, or 2–5 cm with Grade 2 plus high genomic risk or Ki67 ≥20%, or Grade 3.
Patients were randomized 1:1 to ribociclib 400 mg + non-steroidal aromatase inhibitor (NSAI) vs NSAI alone; goserelin could be used as indicated. The primary endpoint was invasive disease-free survival (iDFS).
At final iDFS analysis, 36-month iDFS was 90.7% (95% CI, 89.3–91.8) with ribociclib+NSAI vs 87.6% (95% CI, 86.1–88.9) with NSAI alone (HR 0.749, 95% CI, 0.628–0.892). Overall survival was immature.
Adverse reactions were reported as consistent with the existing ribociclib + NSAI safety profile.
Dosing and storage notes (label)
In the adjuvant setting, recommended ribociclib dosing is 400 mg orally once daily for 21 days on/7 days off per 28-day cycle. Kisqali has updated storage conditions: refrigerate until dispensed; after dispensing, store at room temperature for up to 2 months.