Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) announced receiving clearance from the Brazilian Health Regulatory Agency for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer. This approval allows the drug to be used in positron emission tomography (PET) for detecting prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients suspected of having metastasis or recurrence based on elevated PSA levels.
Product and Mechanism
TLX591-CDx is designed for PET imaging to identify PSMA-positive lesions in prostate cancer patients. It helps in staging the disease and detecting potential metastases or recurrences, providing crucial information for treatment planning.
Market Expansion and Partnerships
Telix Pharmaceuticals has licensed the drug to Brazil-based SH Corp Participações S.A. for local manufacturing, distribution, and marketing. Additionally, the company plans to establish a joint venture (JV) with R2PHARMA to commercialize and distribute its therapeutic and diagnostic radiopharmaceutical products in Brazil, building on their existing partnership since 2019.
Global Presence
Telix Pharmaceuticals has already secured approvals in multiple countries, including Australia, Canada, New Zealand, the US, and the UK. The Brazilian approval further solidifies its global market presence and commitment to expanding access to innovative diagnostic tools for prostate cancer.-Fineline Info & Tech
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