Novartis has secured expanded approval from the U.S. Food and Drug Administration (FDA) for the use of Pluvicto (lutetium-177 [Lu-177] prostate-specific membrane antigen [PSMA]-617) in patients with prostate cancer.
Pluvicto can now be used as therapy in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), in combination with an androgen receptor pathway inhibitor, the company said in a July 31 release. The label update could double the number of patients eligible for the radioligand therapy, according to the company.
Pluvicto was first approved for patients with metastatic castration-resistant prostate cancer after they had exhausted all other treatment options. mHSPC is an earlier form of the disease. The clearance is based on the phase III PSMAddition trial, which in final analysis found that Pluvicto combined with standard of care reduced the risk of progression or death by 33% compared with standard of care alone, Novartis said.
Grade 3 or higher adverse events occurred in 50.7% of patients receiving Pluvicto plus standard of care, compared with 43% of those on standard of care alone, according to the company. The most common all-grade adverse events included dry mouth, fatigue, nausea, hot flush, and anemia, Novartis noted.
