Telix announces Canada approval for Illuccix label expansion

Health Canada has expanded the approved use of Telix Pharmaceuticals’ Illuccix for patient selection in prostate-specific membrane antigen (PSMA) targeted radionuclide therapy.

This label expansion allows Illuccix, a gallium Ga 68 gozetotide injection kit, to be used for identifying progressive metastatic castration-resistant prostate cancer (mCRPC) patients eligible for lutetium (177Lu) vipivotide tetraxetan treatment, also known as Pluvicto.

Since October 2022, Illuccix has been authorised in Canada for staging and re-staging intermediate and high-risk prostate cancer and pinpointing tumour tissue in recurrent cases.

The latest approval enhances the clinical applications of Illuccix, which is distributed by Isologic Innovative Radiopharmaceuticals, reaching 265 hospitals and clinics across the country.

Telix Precision Medicine CEO Kevin Richardson stated: “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.”

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Illuccix, post radiolabelling with gallium (68Ga), is indicated for positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer.

The indications include cases with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence based on elevated serum prostate specific antigen (PSA) levels, and now, for identifying mCRPC patients for whom PSMA-targeted therapy is indicated.

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.”

In February 2024, Telix reached an agreement to buy US-based speciality radiopharmaceutical development and bioconjugation company IsoTherapeutics.

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