Telix Pharmaceuticals has secured regulatory approval from ANVISA for Illuccix®, the first PSMA-PET prostate cancer imaging agent in Brazil. The authorization allows R2PHARMA to manufacture and distribute the product, which targets PSMA for detecting prostate cancer metastasis and recurrence. A joint venture with R2PHARMA aims to enhance commercial access to radiopharmaceuticals in Brazil, addressing the country’s significant prostate cancer burden.
On March 18, 2025, Telix Pharmaceuticals Limited announced the approval of Illuccix® by the Brazilian Health Regulatory Agency (ANVISA), marking its first full regulatory authorization in Latin America. Illuccix® is a gallium-68 (68Ga) gozetotide injection, recognized as the sole PSMA-PET imaging agent for prostate cancer in Brazil. It is indicated for detecting prostate-specific membrane antigen (PSMA) positive lesions in patients, facilitating the diagnosis of suspected metastasis or recurrence based on elevated PSA levels.
The marketing authorization has been granted to R2PHARMA, a leading manufacturer of cold kits and a subsidiary of GSH Corp Participações S.A. Telix has licensed R2PHARMA for the production and distribution of Illuccix® in Brazil. PSMA-PET technology is already in use in countries such as Australia, Canada, New Zealand, and the United States, enhancing diagnostic capabilities for prostate cancer.
Dr. Sérgio Altino de Almeida, a nuclear medicine specialist in Brazil, emphasized the significance of this approval. He stated, “The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil… among all geographic regions, ensuring significant equity of access.”
In addition, Telix announced a joint venture with R2PHARMA to enhance the commercialization of both therapeutic and diagnostic radiopharmaceuticals in Brazil. This partnership aims to innovate and introduce new products in a market projected to grow significantly over the next decade, reaching US$330 million due to rising investments and an aging population.
The joint venture, named Telix Innovations Brazil, will focus on distributing Illuccix® and future product candidates. Rafael Madke, Vice-President of R2PHARMA, expressed enthusiasm for this initiative, highlighting how it will enhance access for patients and physicians to essential diagnostics and treatments currently lacking in Latin America.
Prostate cancer is a leading health concern in Brazil, with over 71,000 new cases and approximately 20,000 deaths in 2023, making such advancements in imaging technology critical for improving patient outcomes. Illuccix® facilitates precise imaging by targeting PSMA, which is prevalent in most prostate cancer cells, thereby enhancing the localization of cancerous lesions during PET scans.
Telix Pharmaceuticals is dedicated to developing therapeutic radiopharmaceuticals, maintaining operations across multiple countries. The company is listed on the ASX and Nasdaq, focused on offering advanced treatments for unmet medical needs, particularly in oncology and rare diseases.
The approval of Illuccix® by ANVISA signals a significant advancement in prostate cancer diagnosis in Brazil. Through the collaboration with R2PHARMA and the establishment of Telix Innovations Brazil, Telix Pharmaceuticals seeks to ensure widespread access to innovative imaging solutions. This partnership not only addresses the growing needs of patients in Brazil but also contributes to the progress of the radiopharmaceuticals market, ultimately enhancing patient outcomes in the battle against prostate cancer. Prostate cancer remains a critical health challenge in Brazil, making the introduction of sophisticated diagnostic tools like Illuccix® vital for effective treatment planning and patient management.
Original Source: www.prnewswire.co.uk
