Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) announced on Wednesday that the European Commission has approved Kisqali (ribociclib) for the adjuvant treatment of a broader population of patients with HR+/HER2- early breast cancer (EBC) at high risk of recurrence.
The approval is based on data from the Phase III NATALEE trial, which demonstrated a significant reduction in the risk of disease recurrence with Kisqali plus endocrine therapy compared to endocrine therapy alone. This benefit was observed across various patient subgroups, including those with node-negative disease.
This broader approval means that nearly twice as many EBC patients in Europe could now be eligible for treatment with Kisqali, helping to reduce their risk of recurrence.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval