Telix Applauds Updated NCCN Guidelines for PSMA-PET Imaging of Prostate Cancer

The National Comprehensive Cancer Network (NCCN) recently updated its guidelines for prostate cancer by including prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging, including Ga- 68 PSMA-11 – a move welcomed by Telix Pharmaceuticals. Telix’s New Drug Application (NDA) for its investigational imaging product Illuccix (Kit for the preparation of 68Ga-PSMA-11 injection) is in the late stages of review by the United States Food and Drug Administration. The NCCN Guidelines are a recognized standard for clinical direction and policy in cancer care and are used widely by clinicians and payors.

Oliver Sartor, MD, Medical Director at Tulane Cancer Center said, “The updated guidelines will encourage clinicians to use PSMA-PET as a primary imaging modality in patients and will deliver the benefit of a more streamlined approach. We look forward to having access to this functional form of imaging as new products come into the market.”

The NCCN panel has recognized the increased sensitivity and specificity of PSMA-PET tracers, compared to conventional imaging (CT, MRI) for detecting micrometastatic disease, at both initial staging and biochemical recurrence. The updated guidelines state that the NCCN Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as equally effective, if not more effective front-line imaging tools for these patients. The updated guidelines now include Ga-68 PSMA-11 PET/CT to be considered as an alternative to standard imaging of bone and soft tissue.

Dr. Colin Hayward, Chief Medical Officer of Telix said, “This is an important change to the guidelines which will influence a shift in clinical practice to consider PSMA-PET imaging as an alternative to standard imaging of bone and soft tissue for the detection of unfavorable intermediate, high and very high risk as well as recurrent prostate cancer.

“The NCCN guidelines are considered a global standard to guide oncology practice and reimbursement. The inclusion of PSMA-PET imaging, including with Ga-68, the isotype used in our investigational imaging product Illuccix further signals the emergence of PSMA-PET imaging as a state-of-the-art imaging modality.”