FDA Approves New Imaging Product for Prostate Cancer

The US Food and Drug Administration (FDA) has approved a prostate cancer imaging kit (Illuccix) for the preparation of gallium-68 (68Ga) gozetotide injection, a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer.

Illuccix — the first commercially available FDA-approved product of its type — is for diagnostic use in men with suspected metastasis who are candidates for initial definitive therapy as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.

68Ga gozetotide, also known as PSMA-11, was approved in 2020 and is the first drug approved specifically for use in PET imaging of PSMA-positive lesions in men with prostate cancer. PSMA-11 has been called a “game changer for detecting metastases, but has also been the subject of concern due to its potential for upstaging and overtreatment and the absence of data about improving patient outcomes.

“The approval of Illuccix will give patients considerably improved access to PSMA-PET imaging, an advanced diagnostic tool that was recently included in the NCCN Clinical Practice Guidelines,” said Oliver Sartor, MD, of Tulane Cancer Center in New Orleans, in a company press statement. The new product allows “flexible patient scheduling and on-demand access” that healthcare professionals “really haven’t seen before,” said Sartor.

With a 4-hour shelf life, the radiopharmaceutical kit can be prepared with 68Ga via GE Healthcare’s FASTlab cyclotrons or in nuclear pharmacies and healthcare centers across the country using Eckert & Ziegler’s GalliaPharm generator or IRE ELIT’s Galli Eo generator.

Illuccix’s maker, Telix, has a distribution network encompassing more than 140 nuclear pharmacies and can provide the kit to more than 85% of eligible PET imaging sites throughout the US.

“Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the US access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body,” Christian Behrenbruch, MD, Telix CEO, said in a statement.

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