Illuccix® Granted Use Authorisation for Prostate Cancer Imaging in Brazil
Melbourne (Australia) and Porto Alegre (Brazil) – 1 December 2021. The Brazilian Health Regulatory Agency has granted an exceptional authorisation for Illuccix® (TLX591-CDx), Telix’s lead prostate cancer imaging product.
Telix is pleased to announce that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘Anvisa’) has granted an exceptional authorisation for Illuccix® (TLX591-CDx) the Company’s lead prostate cancer imaging product.
Illuccix (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) imaging agent targeting prostate specific membrane antigen (PSMA) for the staging of prostate cancer. The exceptional authorisation grants permission to commence selling Illuccix in Brazil, ahead of a full regulatory approval, expected next year.
The authorisation is granted to Telix’s partner MJM Produtos Farmacêuticos e de Radioproteção LTDA (Grupo RPH), Brazil’s leading cold kit plant and radiopharmacy network. RPH has an exclusive licence agreement with Telix to manufacture and distribute Illuccix in Brazil.
The Anvisa approval facilitates wide-spread clinical access to state-of-the-art prostate cancer imaging for all men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals.
Dr. Christian Behrenbruch, CEO and Managing Director of Telix said, “Prostate cancer is the most commonly diagnosed male cancer in Brazil, with approximately 65,840 new cases each year. PSMA-PET imaging has the potential to have a profound impact on the management of prostate cancer, enabling clinicians to detect prostate cancer right throughout the body. We look forward to working closely with our partner RPH to facilitate widespread patient access to Illuccix for men living with prostate cancer in Brazil.”
Grupo RPH Nuclear Medicine & Innovation Vice-President, Rafael Madke, added, “We are very pleased to have received this exceptional authorisation for Illuccix in Brazil, which is only given in select circumstances, and we look forward to playing an important role in transforming outcomes for men with prostate cancer. Grupo RPH is pleased to be working with a global leader such as Telix. We have extensive capability to manufacture and distribute nuclear medicine products in this region, and our objectives to support physicians and patients in Brazil are closely aligned.”
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