Kisqali (ribociclib) approved by the US FDA for the adjuvant treatment of people with HR+/HER2- stage II and III early BC
Approved based on: Phase III NATALEE trial
FDA Approval:
Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence, including those with node-negative (N0) disease.
Results:
Adjuvant Kisqali with endocrine therapy (ET) significantly 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
The invasive disease-free survival (iDFS) benefit was consistently observed across all patient subgroups
Kisquali at 400mg was well-tolerated and discontinuation was mainly due to asymptomatic laboratory findings
Adverse events (AE) of special interest in the investigational arm were neutropenia, liver-related AE, QT interval prolongation, and interstitial lung disease/pneumonitis
Late-breaking results at ESMO showed iDFS benefits beyond 3 years of treatment period across all patient subgroups
Dose:
400 mg (two 200 mg tablets) once daily with or without food, for 3 weeks, followed by one week off treatment, in combination with 4 weeks of any AI
Treatment period:
Three years
Previous approval for Kisqali:
Treatment for metastatic BC in 99 countries including US and EU
US: Adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men
EU: Women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist
Future outlook:
Long-term outcomes including overall survival evaluation
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