FDA Approves Pixclara, a New Imaging Drug for Brain Cancer (Glioma)

The U.S. Food and Drug Administration (FDA) has approved Pixclara (floretyrosine F 18), an amino acid positron emission tomography (PET) drug for imaging gliomas, the most common form of central nervous system cancer. This approval addresses a significant unmet need by helping physicians differentiate recurrent or progressive glioma from treatment-related changes in adult and pediatric patients aged 1 month and older. FET-PET imaging is already recommended in international clinical practice guidelines, and Pixclara is the first FDA-approved product of its kind in the U.S.