Novartis (NYSE: NVS) has announced an update on the late-stage trial for its CDK4/6 inhibitor Kisqali (ribociclib) in early breast cancer. Data from 78.3% of patients who completed treatment showed a significant reduction in the risk of recurrence, with 30% and 24.5% decreases for stage II and stage III tumors, respectively. The safety profile aligns with previous observations, and Novartis plans to submit these data for regulatory review in Europe and the US by the end of the year.
Additionally, the Swiss pharmaceutical giant reported positive results from the extension period of a Phase III study for Fabhalta (iptacopan) in paroxysmal nocturnal hemoglobinuria (PNH) patients with residual anemia despite standard care. The study demonstrated that the first-in-class Factor B inhibitor helped increase hemoglobin levels to near-normal, avoided the need for blood transfusions, and reduced fatigue in most patients. According to the public data, the orphan drug received regulatory approval for PNH in the US last week and is in clinical development for other complement-mediated diseases, including immunoglobulin A nephropathy (IgA nephropathy), C3 glomerulopathy (C3G), immune complex membranoproliferative glomerulonephritis (IC-MPGN), and atypical hemolytic uremic syndrome (aHUS).- Flcube.com
