CAR-T Investigation: FDA Leaders Detail Decision on Cancer Risk Warning
The FDA has identified more cases of secondary T-cell malignancies following treatment with chimeric antigen receptor (CAR) T-cell therapies, cases that led the agency to demand new boxed warnings on approved agents in the class. With about 27,000 doses of the six B-cell maturation antigen (BCMA)- or CD19-directed CAR-T products having been administered in the […]
Case Builds Against Beta-Blockers Beyond First Year After Heart Attack
The conventional wisdom of giving long-term beta-blockers for secondary prevention after myocardial infarction (MI), in the absence of another clinical indication, was questioned by a large cohort study from Sweden. For survivors who were still on beta-blocker therapy 1 year after heart attack hospitalization and had a normal left ventricular (LV) ejection fraction, the next […]
FDA Approves First Treatment for Geographic Atrophy Secondary to AMD
The FDA approved pegcetacoplan injection (Syfovre) as the first treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a statement from Apellis Pharmaceuticals. Primary support for the approval came from the randomized, sham-controlled DERBY and OAKS trials, which showed a 22% overall reduction in growth of GA with pegcetacoplan over 24 […]