FDA approves first imaging drug for brain tumors after one rejection

The U.S. Food and Drug Administration (FDA) has approved the first imaging drug for diagnosing brain tumors, just over a year after rejecting an earlier application.

According to Fierce Biotech on the 15th (local time), the FDA approved Telix’s Pixclara for imaging gliomas. It is the first glioma imaging drug approved in the United States.

Pixclara is an amino acid positron emission tomography (PET) drug. It is used in adults and children aged 1 month and older to distinguish recurrent or progressive glioma from treatment-related changes.

Gliomas account for about 80% of malignant brain tumors, with approximately 24,000 cases occurring in the United States each year.

Although this type of PET imaging is recommended for glioma imaging in international clinical practice guidelines, no approved drug meeting this need was available in the United States.

In a statement, Kevin Richardson, CEO of Telix Precision Medicine, said Pixclara would "increase diagnostic certainty and confidence in patient treatment planning" for U.S. physicians.

Pixclara’s approval process was not smooth. In April last year, the FDA rejected Telix’s application, saying that "additional confirmatory clinical evidence is needed."