Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via the Decentralized Procedure (DCP) for its TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11), a radionuclide-drug conjugate (RDC) for the diagnosis of prostate cancer, has been approved by the regulatory body in the region. This approval marks a significant milestone in the commercialization of this innovative diagnostic tool.
TLX591-CDx: Diagnostic for Prostate Cancer
Originally developed by Telix, TLX591-CDx is a novel RDC diagnostic that targets prostate-specific membrane antigen (PSMA). It is under development to diagnose metastatic and recurrent prostate cancer, offering a new approach to the early detection and management of this disease.
Licensing Agreement with Grand Pharmaceutical Group
In November 2020, China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) licensed the drug from Telix for Greater China rights in a deal worth up to USD 250 million. This strategic partnership aims to expand the reach of TLX591-CDx and bring this advanced diagnostic solution to patients in Greater China.
Regulatory Decision and DCP Process
The regulatory decision follows the issuance of the Final Assessment Report from the German Competent Authority BfArM as Reference Member State (RMS). Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS) have agreed that Illuccix should receive marketing authorization. This approval paves the way for the widespread use of TLX591-CDx in the diagnosis of prostate cancer across Europe.
Strategic Implications
The approval of TLX591-CDx in Europe via the DCP is a strategic achievement for Telix Pharmaceuticals. It underscores the company’s commitment to advancing innovative diagnostics and improving patient outcomes in prostate cancer. By securing marketing authorization in Europe, Telix is well-positioned to expand its global footprint and contribute to the broader goal of enhancing cancer diagnosis and treatment.-Fineline Info & Tech
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