The University of California has secured approval from the US Food and Drug Administration (FDA) for its Gallium 68 PSMA-11 (Ga 68 PSMA-11) drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Ga 68 PSMA-11, a radioactive diagnostic agent, is suitable for administration in the form of an intravenous injection.

It is designated for patients with suspected prostate cancer metastasis who can be cured by surgery or radiation therapy.

The PET imaging drug is also used for patients with suspected prostate cancer recurrence based on elevated serum prostate-specific antigen (PSA) levels.

Ga 68 PSMA-11 binds to PSMA

After it is administered through injection, Ga 68 PSMA-11 sticks to PSMA, a crucial pharmacologic target for prostate cancer imaging as prostate cancer cells generally contain increased levels of the antigen.

The drug, which emits positrons, allows imaging by PET to show the presence of PSMA-positive prostate cancer lesions in the tissues of the body.

Its safety and efficacy has been assessed in two prospective clinical trials with a total of 960 men with prostate cancer who each secured one injection of Ga 68 PSMA-11.

The first trial evaluated 325 patients with biopsy-proven prostate cancer. They underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11.

In addition, the second trial recruited 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy. They also had biochemical evidence of recurrent prostate cancer.

FDA’s Centre for Drug Evaluation and Research’s office of specialty medicine acting deputy director Dr Alex Gorovets said: “Ga 68 PSMA-11 is an important tool that can aid health care providers in assessing prostate cancer.

“With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body.”

The regulator already approved two other PET drugs, including F 18 fluciclovine and C 11 choline, for prostate cancer imaging. They have been only approved for use in patients with suspected cancer recurrence.

In October this year, Varian secured an investigational device exemption (IDE) approval from FDA to begin a clinical trial of FLASH therapy.