Health Canada Expands Approval Scope for Telix Product Illuccix

Health Canada has expanded the application areas for Telix Pharmaceuticals' product Illuccix. The Gallium Ga 68 Gozetotide injection kit can now also be used to select patients with progressive metastatic castration-resistant prostate cancer (mCRPC) who are considered for treatment with Lutetium (177Lu) Vipivotide Tetraxetan, known as Pluvicto. Since October 2022, Illuccix has been approved in Canada for staging and restaging in intermediate- and high-risk prostate cancer and helps localize tumor tissue in recurrent cases. The current approval extends the clinical applications of the product, which is distributed on a national level by Isologic Innovative Radiopharmaceuticals to 265 hospitals and clinics. Kevin Richardson, CEO of Telix Precision Medicine, emphasized the significance of this decision by Health Canada. It allows for improved access to advanced imaging for prostate cancer and provides critical information to doctors for informed therapy decisions. This underscores Telix's commitment to supporting cancer patients and their treating physicians through various stages of the patient journey. Illuccix, which upon radiolabeling is a positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer, now shows expanded indications. These include patients with suspected metastases eligible for initial definitive therapy, cases of suspected recurrence based on elevated PSA levels, and now also mCRPC patients for whom PSMA-targeted therapy is indicated. André Gagnon, President of Isologic, commented, "PSMA-targeted theranostics is considered the future of prostate cancer treatment. It is therefore great that we can now offer Illuccix in this expanded application area through our nationally distributed network." Additionally, in February 2024, Telix reached an agreement to acquire US-based radiopharmaceutical and bioconjugation specialist IsoTherapeutics.