Australia-based Telix Pharmaceuticals announced a favorable decision from the European Union (EU) in relation to marketing authorization for Illuccix in prostate cancer (PCa) PET imaging.
Telix said in Europe, Illuccix, after radiolabeling with gallium-68, will be indicated for detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with PCa in the following clinical settings:
- Primary staging of patients with high-risk PCa prior to primary curative therapy.
- Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.
- Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.
The company submitted its Marketing Authorization Application (MAA) for Illuccix (kit for the preparation of gallium-68 gozetotide injection) via a decentralized procedure (DCP). The DCP regulatory process will now transition into an administrative national phase to implement authorizations to facilitate commercial launch in each country, according to Telix.
Telix launched Illuccix for prostate cancer imaging in 2022 in the U.S. The latest milestone in the EU follows the issuance of the Final Assessment Report from the German Federal Institute for Drugs and Medical Devices (BfArM), Telix added. Illuccix is approved in Australia and Canada as well, the company noted.
