Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 20 December 2021. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company), a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on molecularly targeted radiation (MTR), today announces that the United States Food and Drug Administration (FDA) has approved Telix’s lead prostate cancer imaging product, Illuccix®.
Illuccix is a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:
suspected metastasis who are candidates for initial definitive therapy;
Ad Statistics
Times Displayed: 50213
Times Visited: 1424 Ampronix, a Top Master Distributor for Sony Medical, provides Sales, Service & Exchanges for Sony Surgical Displays, Printers, & More. Rely on Us for Expert Support Tailored to Your Needs. Email info@ampronix.com or Call 949-273-8000 for Premier Pricing.
suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
“The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1 for Prostate Cancer,” said Dr. Oliver Sartor, Medical Director at Tulane Cancer Center. “With patient doses able to be prepared on-site or via commercial radiopharmacy networks, either via generator or cyclotron, Illuccix delivers flexible patient scheduling and on-demand access throughout the day.”
Illuccix is the first commercially available FDA-approved product to enable wide accessibility to 68Ga- based PSMA-PET imaging for physicians and eligible patients across the United States. Illuccix can be prepared with 68Ga via either GE’s FASTlabTM cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm® generator or IRE ELIT’s Galli Eo® generator. This optionality along with a four-hour shelf life after radiolabeling with 68Ga, enables Illuccix to flexibly extend the reach of advanced PSMA-PET imaging to patients across the country.
“This product offers a level of flexibility and accessibility to healthcare professionals we really haven’t seen before in this class of products and may help us provide better patient experiences as a result,” said Dr. Sartor.
With a distribution network encompassing more than 140 nuclear pharmacies through its agreements with Cardinal Health and PharmaLogic, Telix will be able to provide Illuccix to more than 85% of eligible PET imaging sites throughout the United States.
