Second Industry Body Updates Guidance for Use of PSMA PET Imaging

MELBOURNE, Australia and INDIANAPOLIS, Sept. 20, 2021 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) has today welcomed the Society of Nuclear Medicine and Molecular Imaging (SNMMI) updated Appropriate Use Criteria (AUC) for prostate specific membrane antigen (PSMA) positron emission tomography (PET) imaging.

The updated AUC, developed following a critical review of evidence by leading experts to guide referring and imaging physicians on the appropriate use of imaging agents, recognise a widespread use of PSMA PET in men with prostate cancer including that PSMA PET-based imaging has a higher accuracy in the initial staging evaluation of men with newly diagnosed prostate cancer than conventional imaging (bone scan and CT).

The AUC are based on scientific evidence and were developed collaboratively between SNMMI, the American College of Nuclear Medicine (ACNM), the American Urological Association (AUA), the Australia and New Zealand Society of Nuclear Medicine (ANZSNM), and the American Society of Clinical Oncology (ASCO) for the appropriate use of PSMA PET, specifically for the diagnosis and management of prostate cancer.

It follows updated guidance from the National Comprehensive Cancer Network^® (NCCN)¹, which recognises the increased sensitivity and specificity of PSMA PET tracers, compared to conventional imaging for detecting micrometastatic disease, at both initial staging and biochemical recurrence.

The systematic review² also noted:

• PSMA PET may have additional use in selecting patients for PSMA directed therapy and assessing response to therapies.
• PSMA PET radiotracers, similar to other radiopharmaceuticals, have an excellent safety profile, given the sub-pharmacological mass dose and high specific activity administered.
• Although there may be small differences between each PSMA PET radiopharmaceutical currently approved or being evaluated by the US Food and Drug Administration, there is no evidence to date that one specific radiopharmaceutical has improved diagnostic characteristics compared with another.
• Integration of AUC into clinical decision support tools may lead to a more efficient reimbursement approval process for advanced diagnostic imaging procedures, including radiology and nuclear medicine procedures, by allowing healthcare providers to track comparisons between the AUC model and the payer’s reimbursement strategy.

Dr Colin Hayward, Chief Medical Officer of Telix said, “Alongside recent NCCN updated guidance, this latest endorsement by the SNMMI will further influence the shift in clinical practice to consider PSMA PET imaging as an alternative to conventional imaging of bone and soft tissue for the detection of prostate cancer. These user guidelines are also important in driving private payer reimbursement, as more healthcare providers adopt PSMA PET and demonstrate its benefit to patients, in more accurate staging and diagnosis.”

Dr. Jeremie Calais, Director of the UCLA Theranostics Program added, “Along with updated NCCN Guidelines and Medicare coverage, this is great news for patients. Private insurers should follow soon. Access to PSMA PET will be widely available and this game-changer technology will ultimately become part of the routine staging of prostate cancer patients. Like doing a PSA test, I anticipate in a near future that physicians will routinely require a PSMA PET scan before making a treatment plan.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix’s lead investigational product, Illuccix^® (TLX591-CDx) for prostate cancer imaging, has been accepted for filing by the U.S. FDA,³ and is under priority evaluation by the Australian Therapeutic Goods Administration (TGA).⁴ Telix is also progressing marketing authorisation applications for Illuccix® in the European Union⁵ and Canada.⁶ None of Telix’s products have received a marketing authorisation in any jurisdiction.

Telix Media Contact

Dr. Stewart Holmstrom
Telix Pharmaceuticals Limited
Director Corporate Communications
Email: stewart.holmstrom@telixpharma.com

¹ https://www.nccn.org/guidelines/category_1
² https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=38657
³ ASX disclosure 24/11/20.
⁴ ASX disclosure 14/04/21.
⁵ ASX disclosure 1/05/20.
⁶ ASX disclosure 16/12/20.