Novartis today announced results from the extension period of the pivotal Phase III APPLY-PNH trial of oral monotherapy Fabhalta® (iptacopan) in adults with paroxysmal nocturnal hemoglobinuria (PNH) who had residual anemia (hemoglobin <10 g/dL) despite previous anti-C5 therapy1,2. Continuous Fabhalta treatment (200 mg twice daily) for 48 weeks enabled sustained hemoglobin-level increases to near-normal (12 g/dL or more), blood transfusion avoidance, and reduced patient-reported fatigue in the ma
On Nov. 28, the Food and Drug Administration (FDA) announced that it was opening an investigation into the possibility of previously unknown serious safety risks associated with the hottest and most technological group of cancer medicines produced to date. Now, drugmakers including Novartis (NYSE: NVS), Gilead Sciences (NASDAQ: GILD), and Bristol Myers Squibb (NYSE: BMY) are on the hot seat, with their patients' well-being and billions of dollars in revenue on the line. The FDA is concerned about chimeric antigen receptor T-cell (CAR T-cell) therapies.
With 5.6 months of additional follow-up and 78.3% of patients having completed Kisqali® (ribociclib) investigational treatment, the updated analysis shows sustained iDFS benefit and stability in secondary endpoints including overall survival (OS)1,2 iDFS benefit remains consistent across key patient subgroups; among patients with stage II and stage III tumors, Kisqali lowered risk by 30% and 24.5%, respectively1,2 Latest analysis continues to show a well-tolerated safety profile in line with pre