Telix Pharmaceuticals has gained marketing authorization for Illuccix®, its prostate cancer imaging agent, from ANVISA in Brazil. This approval marks Illuccix® as the first PSMA-PET imaging agent authorized in the country, enhancing diagnostic accuracy for prostate cancer. A joint venture with R2PHARMA will facilitate its distribution in Brazil, addressing the growing market demand for radiopharmaceuticals amidst rising cancer prevalence.
Telix Pharmaceuticals Limited has announced that its prostate cancer imaging agent, Illuccix®, has received marketing authorization from the Brazilian Health Regulatory Agency (ANVISA). This landmark approval marks Illuccix® as the first and only PSMA-PET imaging agent authorized in Brazil. The approval allows for state-of-the-art diagnostic capabilities for detecting prostate cancer, particularly in patients with suspected metastasis or recurrence, thereby enhancing precision in treatment planning.
Illuccix®, after being radiolabeled with gallium-68, is specifically designed for positron emission tomography (PET) imaging to identify prostate-specific membrane antigen (PSMA) positive lesions. The drug will be marketed through Telix’s collaboration with R2PHARMA, Brazil’s leading cold kit manufacturer and a subsidiary of GSH Corp Participações S.A., which has exclusive rights to manufacture and distribute Illuccix®.
The growing radiopharmaceuticals market in Brazil is projected to reach $330 million in the next decade, bolstered by advancements in imaging technologies and a rising prevalence of cancer. Telix and R2PHARMA also launched a joint venture to distribute innovative therapeutic and diagnostic products across Brazil.
Dr. Sérgio Altino de Almeida emphasized the significance of this approval, stating that it enables broader access to advanced imaging services for prostate cancer across different regions in Brazil. This initiative is expected to further bolster equity in healthcare access for prostate cancer patients nationwide.
Raphaël Ortiz, CEO of Telix International, expressed optimism about bringing Illuccix® to Brazil and Latin America. He noted that the imaging modality had already been integrated into leading clinical guidelines globally, representing a crucial advancement for prostate cancer care in the region. The collaboration with R2PHARMA aims to address gaps in therapeutic and diagnostic radiopharmaceuticals within diverse medical needs.
Prostate cancer remains the most prevalent cancer in males in Brazil, with projections indicating 71,730 new cases in 2023 and approximately 20,000 deaths attributed to the disease in 2022. Illuccix® plays a critical role in diagnosing and managing this serious health concern, confirming its significance for patient outcomes in Brazil. As Telix continues to expand its global footprint from its headquarters in Melbourne, the availability of Illuccix® in Brazil marks a crucial step forward for addressing prostate cancer diagnostics.
The approval of Illuccix® by ANVISA represents a transformative development in prostate cancer diagnostics in Brazil, promising enhanced accessibility to advanced imaging technologies for patients. Amidst growing demand for radiopharmaceuticals and the establishment of a strategic joint venture with R2PHARMA, Telix Pharmaceuticals is poised to significantly impact cancer care in the region. This advancement is critical in light of the high incidence rates of prostate cancer, supporting improved patient outcomes through innovative diagnostic solutions.
Original Source: www.globenewswire.com
