FDA clears Pluvicto earlier in PSMA positive metastatic prostate cancer

The U.S. Food and Drug Administration has authorized Pluvicto for use with standard hormone blocking regimens in adults with PSMA positive metastatic hormone sensitive prostate cancer. The decision allows clinicians to combine the radioligand therapy with androgen deprivation and androgen receptor pathway inhibitors in patients whose disease is still hormone sensitive, significantly increasing the group eligible for this targeted approach.

PSMAddition data underpin the label expansion

Regulatory reviewers relied on results from the Phase 3 PSMAddition trial.

• In the primary analysis, adding Pluvicto to standard care reduced the risk of radiographic progression or death by 28 percent compared with hormone therapy and androgen receptor blockade alone.

• A later cut of the data showed a 33 percent reduction in progression or death with the combination, along with a favorable overall survival trend that continues to mature.

Investigators and treating oncologists note that moving radioligand therapy earlier in the pathway supports more intensive upfront strategies before resistance develops.

Need for earlier precision approaches

The new indication extends Pluvicto use beyond its prior focus on castration resistant disease, giving a precision option in hormone sensitive metastatic settings as well.

In routine practice, many men with metastatic hormone sensitive prostate cancer progress within roughly twenty months on conventional doublet regimens, and a substantial fraction do not achieve undetectable PSA, underscoring the limits of current standards. Because PSMA expression is seen in most prostate cancers, PSMA targeted radioligand therapy has the potential to reach a broad segment of the advanced patient population.

Safety profile and infrastructure

Safety findings in PSMAddition were in line with earlier Pluvicto studies, with dry mouth, fatigue, nausea, hot flushes and anemia among the most frequent adverse events, and grade 3 or higher toxicities occurring in around half of patients receiving the combination.