Novartis Pluvicto Wins FDA Approval for Earlier Use, Doubling Patient Pool

The U.S. Food and Drug Administration (FDA) expanded the approval for Novartis’s targeted radioligand therapy, Pluvicto.

The FDA now authorizes the drug for use with an androgen receptor pathway inhibitor (ARPI) to treat PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). This decision allows clinicians to use the treatment in earlier stages of metastatic prostate cancer.

The Phase III PSMAddition clinical trial showed the Pluvicto combination significantly reduced the risk of disease progression or death. Novartis estimates this expanded indication will nearly double the number of patients eligible for the treatment.