Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Approves New Treatments For Triple-Negative Breast Cancer And Chronic Hepatitis D
The FDA on Friday approved datopotamab deruxtecan (Dato-DXd; Datroway) as a first-line option for unresectable or metastatic triple-negative breast cancer patients ineligible for immunotherapy. (Bassett, 5/26)
Chronic hepatitis delta virus (HDV) infection has its first FDA-approved treatment, after the agency granted accelerated approval to bulevirtide (Hepcludex) injection for adults without cirrhosis or with compensated cirrhosis. The most severe form of viral hepatitis, HDV infection only occurs in people with hepatitis B virus (HBV) infection and brings greater risks of disease progression, liver failure, and mortality than HBV alone. An estimated 40,000 people in the U.S. have chronic HDV. Bulevirtide blocks entry of both HBV and HDV into liver cells. (Rudd, 5/26)
In other research —
Scientists from the University of Pennsylvania have identified an immune-system protein that facilitates the spread of Parkinson’s disease to new brain cells and regions. (Hille, 5/27)
An investigational gene therapy passed muster for reducing PCSK9 and LDL cholesterol levels, with reassuring safety, among patients with heterozygous familial hypercholesterolemia (HeFH) or premature coronary artery disease (CAD), an interim analysis of a phase Ib trial suggested. (Lou, 5/26)
Chanel Robinson achieved exactly what the gold rush of blockbuster weight-loss drugs promised: She lost nearly 100 pounds, lowered her cholesterol to normal levels and reined in her polycystic ovary syndrome. Yet, nearly three years into her journey on Mounjaro, the 30-year-old from Atlanta, Ga., is discovering the hidden costs of the slimmed-down life. (Dangoor, 5/26)
