Brazilian Health Regulatory Agency (ANVISA) has granted approval for Telix Pharmaceuticals’ Illuccix, a prostate cancer imaging agent.
Illuccix claims to be the first prostate-specific membrane antigen-positron emission tomography (PSMA-PET) imaging agent to receive full regulatory approval in Brazil.
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It is a kit that is used for preparing gallium-68 (⁶⁸Ga) gozetotide injection for PET imaging in conjunction with computerised tomography (CT) scan for identifying and localising recurrent cancerous lesions in situations where prostate cancer relapse is suspected in the adult male population.
According to the company, the imaging agent is indicated for detecting PSMA-positive lesions in individuals with suspected metastasis who are initial therapy candidates and for those with suspected recurrence depending on elevated serum-specific antigen levels.
Grupo GSH subsidiary and Telix’s Brazilian partner R2PHARMA secured the marketing authorisation for the imaging agent.
Known for its offerings in nuclear pharmacy and cyclotron networks, R2PHARMA is responsible for manufacturing, distributing, and marketing the imaging agent exclusively in Brazil under the licence provided by Telix.
PSMA-PET imaging technology is leveraged to identify advanced prostate cancer. ANVISA’s approval aligns with the global recognition of Illuccix, which is already available in the US, Canada, New Zealand, Australia, the UK, and several nations within the European Economic Area (EEA).
Telix and R2PHARMA have announced a joint venture (JV) for commercialising and distributing the former’s therapeutic and diagnostic radiopharmaceutical products in the country, building upon their partnership established in 2019.
The Telix Innovations Brazil JV will carry the exclusive licence for commercialising Illuccix and Telix’s theranostic pipeline’s future product candidates in the country.
Telix International CEO Raphaël Ortiz said: “Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognised in leading clinical practice guidelines and already being adopted in other parts of the world.
“We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil.”
In November 2024, Telix dosed the first subject in its Phase III ZIRCON-CP trial of TLX250-CDx, a PET imaging form tailored to examine clear cell renal cell carcinomas.
