The technique offers an extended distribution radius compared to existing gallium-based imaging products
The FDA has approved a New Drug Application for Telix Pharmaceuticals’ Gozellix, a PSMA-PET imaging agent for prostate cancer.
“With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men,” said Telix CEO Kevin Richardson.
Gozellix uses radiolabelling with Gallium-68. This involves attaching a positron-emitting radionuclide to molecules for use in PET imaging, enabling the visualisation of specific biomarkers and processes in the body.
The imaging technique is suitable for men with prostate cancer who have suspected metastasis who are candidates for initial definitive therapy, as well as those with suspected recurrence based on elevated PSA level.
Gozollix has a shelf life of up to six hours and offers an extended distribution radius compared to existing gallium-based imaging products.
The ability to deliver the product further from its point of production means Gozellix can reach PET cameras that are currently not served by PSMA imaging providers. This enables accurate gallium-based imaging to more patients.
While PSMA-PET imaging is slowly becoming the standard of care for prostate cancer imaging due to its accuracy, so far only a small portion of men have undergone this type of precision medicine scan.
FDA’s new drug application approval of Gozellix indicates an increasing normalisation of PSMA-PET imaging for prostate cancer patients.
