Therapy Areas: Oncology
Telix Pharmaceuticals receives Illuccix approval from FDA for supplementary New Drug Application
17 March 2023 -

Telix Pharmaceuticals Limited (ASX:TLX)(Telix), a biopharmaceutical company, announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for its supplementary New Drug Application (sNDA) for Illuccix(R) to allow its use for a section of patients with metastatic prostate cancer, for whom 177Lu 177 PSMA-directed therapy is indicated.

The label expansion indicates that the product is now approved in the US to certain subjects who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA), providing doctors with critical information to help guide treatment decisions. In order to qualify for radioligand therapy, subjects must be imaged with an approved gallium-based PSMA-PET agent.

The product, a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in subjects with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level and for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.

Kevin Richardson, CEO for Telix Americas said, 'We welcome the FDA's decision to expand the label indication for Illuccix. This additional indication further demonstrates our continued commitment to support patients fighting prostate cancer and to empower the doctors who treat them. Clinicians now have the ability to use Illuccix in more stages of the patient journey, to confidently and accurately detect and help manage this disease.'