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Melbourne and Indianapolis, Australia, December 20, 2021 (GLOBE NEWSWIRE) – Telix Pharmaceuticals Limited (Australian Stock Exchange code: TLX, Telix, Inc.) is a global biopharmaceutical company focused on the development of molecular targeting Radiation Diagnostic and Therapeutic Products (MTR), today announced that the U.S. Food and Drug Administration (FDA) has approved Telix’s leading prostate cancer imaging product, Illuccix®.
Illuccix is a kind of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent, suitable for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer:
- People who are suspected of having metastases are candidates for preliminary definitive treatment;
- Suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
“Illuccix’s approval will greatly improve patients’ access to PSMA-PET imaging. PSMA-PET imaging is an advanced diagnostic tool that has recently been included in the NCCN Oncology Clinical Practice Guidelines (NCCN Guidelines®)1 For prostate cancer,” said Dr. Oliver Sartor, Medical Director of Tulane Cancer Center. “Patient doses can be prepared on-site or through commercial radiopharmaceutical networks (via generators or cyclotrons), and Illuccix provides flexible patient scheduling and on-demand throughout the day access. “
Illuccix is the first commercial product approved by the FDA and is widely available 68Ga-based PSMA-PET imaging for American doctors and eligible patients. Illuccix can be used 68Ga uses GE’s FASTlab™ cyclotron or Eckert & Ziegler’s GalliaPharm in nuclear pharmacies and medical centers nationwide® Generator or Galli Eo of IRE ELIT® Dynamo.This selectivity and four-hour shelf life after radiolabeling 68Ga enables Illuccix to flexibly extend the advanced PSMA-PET imaging range to patients across the country.
“This product provides healthcare professionals with a degree of flexibility and accessibility that we have never seen before in this type of product, and therefore may help us provide a better patient experience,” said Dr. Sartor.
Through agreements with Cardinal Health and PharmaLogic, Telix’s distribution network covers more than 140 nuclear pharmacies and will be able to provide Illuccix to more than 85% of eligible PET imaging sites in the United States.
“This heralds a new era of gallium-based PSMA-PET imaging for patients and doctors, and marks Telix’s entry into an important new phase as we bring our first commercial product to the US market,” Managing Director Christian Said Dr. Behrenbruch and CEO of Telix. “Improved imaging can provide doctors with insight to determine the most appropriate…
The full story can be found on Benzinga.com
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