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FDA Approves Telix Pharmaceuticals' Gallium-Labeled PET Imaging Agent as CDx for Novartis' Pluvicto

NEW YORK – The US Food and Drug Administration on Thursday approved Telix Pharmaceuticals' Illuccix (Ga-68 PSMA-11) as a companion diagnostic for selecting advanced prostate cancer patients eligible for treatment with Novartis' Pluvicto (177Lu-PSMA-617).

To be eligible for treatment with Novartis' prostate specific membrane antigen (PSMA)-directed radiopharmaceutical, patients with previously treated metastatic castration-resistant prostate cancer (mCRPC) must undergo PET imaging with an approved gallium-based agent to ensure their tumors express PSMA.

When Pluvicto was approved last year, the FDA listed Novartis' gallium-based imaging agent, Locametz (gallium Ga 68 gozetotide), on the label as a companion diagnostic for selecting eligible patients.

Illuccix is already FDA approved as a diagnostic agent to image prostate cancer patients with suspected metastases who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. The FDA granted Illuccix this new expanded approval based on the fact that Illuccix was used to select patients in the Phase III VISION trial that led to Pluvicto's approval.

The FDA's decision to approve Illuccix as a tool for Pluvicto patient selection comes as Novartis faces continued supply issues, culminating in a decision to halt new patient starts on the radioligand therapy earlier this month.

In a statement detailing the new Illuccix approval, Telix referenced the "reliability and flexibility of Telix's distribution network," which it believes could help improve access to imaging for patients who are candidates for radioligand therapy.

Telix, of note, is also working to develop its own PSMA-targeted radiopharmaceutical, dubbed TLX591, for PSMA-expressing prostate cancer patients.

Citing statistics from the American Cancer Society, Telix said that around 32,000 patients per year in the US may be considered for treatment with a PSMA-directed radioligand.