Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has approved ribociclib (Kisqali, Novartis) with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, HER2-negative stage II and III early breast cancer at high risk for recurrence. The FDA also approved the ribociclib and letrozole co-pack (Kisqali Femara Co-Pack, Novartis) for the same indication.

Efficacy of ribociclib with a nonsteroidal aromatase inhibitor (NSAI) was evaluated in NATALEE (ClinicalTrials.gov. Identifier: NCT03701334), a randomized, open-label, multicenter trial in 5101 adults with HR-positive, HER2-negative early breast cancer. 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 tumor size 2 to 5 cm with either grade 2 (and high genomic risk or Ki-67 ≥20%) or grade 3.

Participants were randomized (1:1) to receive ribociclib (400 mg) plus an NSAI or NSAI alone; patients could receive goserelin as indicated. Randomization was stratified by anatomic stage, prior chemotherapy (neoadjuvant vs. adjuvant), menopausal status (premenopausal and males vs. postmenopausal) and region (North America/Western Europe/Oceania vs. rest of the world).

The main efficacy outcome measure was invasive disease–free survival (iDFS), which was defined as randomization to the first occurrence of the following: 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).

A statistically significant improvement in iDFS was observed in the intent-to-treat patient population at an interim analysis. Efficacy results at the final iDFS analysis showed that iDFS at 36 months was 90.7% (95% CI, 89.3%-91.8%) in the ribociclib plus NSAI arm and 87.6% (95% CI, 86.1%-88.9%) in the NSAI arm, with a hazard ratio of 0.749 (95% CI, 0.628- 0.892). At the time of the iDFS final analysis, overall survival was immature.

The adverse reactions observed on the NATALEE trial were consistent with the current safety profile for ribociclib in combination with an NSAI. The prescribing information provides additional safety information.

Ribociclib has newly updated storage conditions. The drug should now be refrigerated until dispensed to patients. After dispensing, healthcare providers should advise patients to store ribociclib at room temperature for up to two months.

The full prescribing information for Kisqali  and Kisqali Femara Co-Pack are posted here.

Based on a press release from the FDA.