The US Food and Drug Administration over the weekend approved Telix Pharmaceutical's Pixclara, a radioactive intravenous infusion that binds to brain cancer cells so they are highlighted on PET scans.
Physicians currently find it challenging to determine whether a patient's glioma is worsening or whether changes on a scan are the result of treatment, doctors say.
Chemotherapy can cause dead cells to accumulate around brain tumours, making it appear on standard imaging scans that they are still growing, a phenomenon known as "pseudoprogression."
"The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI," said Kelly Sitkin, the president and chief executive of the American Brain Tumor Association.
The imaging agent will provide US physicians with more certainty in their diagnoses and greater confidence in their treatment planning for patients, said Kevin Richardson, chief executive of Telix's precision medicine arm.
There are 24,000 new glioma cases diagnosed each year in the United States, making them the most common type of malignant brain tumour in adults.
The US authority had knocked back Telix's initial submission for Pixclara in April 2025, asking for more clinical evidence to support the drug application.
RBC Capital Markets analyst Craig Wong-Pan said the approval demonstrated Telix's ability to overcome the setback of the initial rejection.
Telix currently has two approved products on the market, Illuccix and Gozellix, which are similar radioactive imaging agents used to highlight prostate cancer tumours on PET scans.
The company made $US477 million ($677 million) in sales in the six months to June 30, up from $US390 million a year ago.
Telix shares were changing hands at $16.24, up 3.6 per cent, just after noon, after rising above six per cent earlier in the day.
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