Medical Technology

FDA Approves New Imaging Product for Prostate Cancer

The US Food and Drug Administration (FDA) has approved the use of a prostate cancer imaging kit (Illuccix) for the preparation of gallium-68 (68Ga) gozetotide injections, a radioactive diagnostic agent indicated for the 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 patients with suspected metastasis who are candidates for the initial definitive treatment as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.

PSMA-11, also known as 68Ga gozetotide was approved in the year 2020. It is the first drug specifically approved for PET imaging of PSMA positive prostate cancer patients. PSMA-11 has been described as an “game-changer” for detecting metastatic cancers. However, it has also been a source of issue because of its potential for escalating or overtreatment and the lack of data regarding improving patient outcomes.

“The approval of Illuccix will give patients a significantly improved access to PSMA PET imaging, an advanced diagnostic tool which 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 offers “flexible patient scheduling and instant access” that healthcare professionals “really haven’t had before,” said Sartor.

The radiopharmaceutical kit has a shelf-life of 4 hours and can be made with 68Ga using GE Healthcare’s FASTlab cyclotrons, or in nuclear pharmacies across the United States using Eckert Ziegler’s GalliaPharm generator.

Telix the manufacturer of Illuccix is a distributor network that spans more than 140 nuclear pharmacies. It is able to supply the Illuccix kit to more than 85 percent of US PET imaging sites.

“Improved imaging can provide physicians with the insights to determine the best treatment path and also give patients in the US access to a unique and precise imaging device for the detection of prostate cancer throughout the body,” Christian Behrenbruch, MD, Telix CEO, said in a statement.

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