Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Kisqali (ribociclib) for the adjuvant treatment of HR+/HER2- early breast cancer (EBC) at high risk of recurrence.
This recommendation is based on data from the Phase III NATALEE trial, which showed that Kisqali plus endocrine therapy (ET) reduced the risk of recurrence by 25.1% compared to ET alone.
"One-third of people diagnosed with stage II breast cancer and more than half of those diagnosed with stage III will unfortunately experience a return of their cancer in the long term, often as metastatic disease," said Peter A. Fasching, M.D., Professor of Translational Medicine at University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. "If approved, Kisqali could provide an effective and tolerable adjuvant treatment option to mitigate the risk of recurrence in a broader patient population, particularly for patients who currently have limited treatment options, including those with high-risk node-negative disease."
The CHMP's positive opinion means that the European Commission could approve Kisqali for this indication within two months.
Sanofi and Orano partner to advance radioligand therapies
RaySearch secures RayStation orders from French cancer centers under Unicancer agreement
HUTCHMED's TAGRISSO plus ORPATHYS shows promise in lung cancer treatment
Anixa Biosciences administers second dose of CAR-T therapy to individual patient
AtomVie Global Radiopharma partners with Radiopharm Ventures
Lipella granted patent for innovative drug delivery technology
RedHill Biopharma's opaganib selected for Ebola treatment development by BARDA
Quest Diagnostics acquires OhioHealth lab assets
Exelixis and Merck collaborate on clinical development of zanzalintinib
BD launches automated reagent kit to streamline single-cell discovery studies