On Friday, Novartis AG (NYSE:NVS) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Kisqali (ribociclib).
The CHMP recommended approval granting marketing authorization for Kisqali (ribociclib) for the adjuvant treatment of adults with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC), at high risk of disease recurrence, including those with node-negative disease.
Also Read: Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts.
The CHMP decision is based on data from the Phase 3 NATALEE trial.
In the trial, Kisqali plus endocrine therapy (ET), compared to ET alone, lowered the risk of cancer recurrence by 25.1% in patients with stage II and III HR+/HER2- EBC.
The data also demonstrated a consistent, clinically meaningful invasive disease-free survival (iDFS) benefit across key pre-specified subgroups.
Data from the pivotal trial also showed that the safety profile of Kisqali at the 400mg dose was well-tolerated, with generally low-grade symptomatic adverse events.
The European Commission (EC) will decide in approximately two months.
Last month, Novartis released new data from the ALITHIOS open-label extension study.
Data show first-line Kesimpta (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from Sanofi SA‘s Aubagio (teriflunomide).
Price Action: NVS stock is up 0.35% at $116.92 at last check Friday.
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