Novartis and Advanced Accelerator Applications, the radioligand business of Novartis, has announced that their investigational treatment, Pluvicto™, was approved by the FDA. Pluvicto, lutetium Lu 177 vipivotide tetraxetan (formerly referred to as 177Lu-PSMA-617) is the first approved targeted radioligand therapy for the treatment of men with progressive, PSMA‑positive metastatic castration-resistant prostate cancer.

Specifically, the approval is only for the treatment of men with advanced prostate cancer that is metastatic (spread outside the prostate gland), castrate resistant (no longer responding to primary hormone therapy), and be prostate-specific membrane antigen (PSMA) positive. The approval also includes the requirement that the men should have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).

To confirm that the prostate cancer is PSMA positive, meaning that the tumor expresses the target, PSMA, along with the approval of Pluvicto, the FDA also approved a complementary diagnostic imaging agent, Locametz. Locametz is a radiolabeling method using gallium-68 to confirm and identify PSMA-positive lesions. Not all prostate cancer expresses PSMA. Since Pluvicto uses PSMA as a target, it will only be effective for those PSMA positive cancers.

The approval was based on pivotal Phase III VISION trial, where men with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death over those just treated with the standard of care (SOC).

The most common adverse events (all grades) in the Pluvicto arm of the study were fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%).

Novartis also is running two additional Phase III studies evaluating Pluvicto in earlier stages of treatment for men with metastatic prostate cancer.