Health Canada has authorised the use of Telix Pharmaceuticals’ Illuccix for patient selection in prostate-specific membrane antigen (PSMA) targeted radionuclide therapy.
Illuccix, a Schedule C radiopharmaceutical product, is a gallium Ga 68 gozetotide injection preparation kit.
The expanded approval allows Illuccix to be used for identifying patients with progressive metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with the approved PSMA-targeted therapy, Pluvicto (lutetium (177Lu) vipivotide tetraxetan).
To be eligible for this therapy, patients must undergo imaging with an approved gallium-based PSMA-PET agent.
The latest approval enhances the clinical use of Illuccix, which has been available in Canada since October 2022. The kit is being used for staging and re-staging intermediate and high-risk prostate cancer, as well as for localising tumour tissue in recurrent prostate cancer.
Telix Precision Medicine CEO Kevin Richardson said: “We welcome Health Canada’s decision to expand the label for Illuccix. This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence.
“This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.”
Illuccix is distributed across Canada through Telix Pharmaceuticals’ partner, Isologic Innovative Radiopharmaceuticals. Isologic’s network services 265 hospitals and clinics in Canada.
The kit is already approved by the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
Isologic president André Gagnon stated: “PSMA-targeted theranostics are widely considered to be the future of prostate cancer treatment.
“It is therefore tremendous that we can now offer Illuccix in this additional setting, for patients who are candidates for PSMA-targeted therapy, through our national network.”
Illuccix, after radiolabelling with gallium (68Ga), is already approved for use with positron emission tomography (PET) to detect PSMA-positive lesions in men with prostate cancer.
The indication covers men with suspected metastasis who are suitable for initial definitive therapy. It is also used for those with suspected recurrence and elevated serum prostate-specific antigen (PSA) levels.
Additionally, the radiopharmaceutical product helps identify patients with progressive mCRPC who are eligible for PSMA-targeted therapy.
Australia-based Telix Pharmaceuticals develops and commercialises therapeutic and diagnostic radiopharmaceuticals and associated medical devices.
In February this year, the company agreed to acquire US-based speciality radiopharmaceutical development and bioconjugation firm IsoTherapeutics.
