Novartis (NVS) said Sunday its Pluvicto prostate cancer medication combined with standard care lowered the risk of disease progression by 58% compared to standard care alone in a clinical trial.

The combination therapy achieved deeper reductions in prostate-specific antigen levels at 12, 24, and 48 weeks, while severe adverse events occurred in 50.7% of patients receiving the regimen compared to 43% in the control group, the company said.

The combination therapy achieved deep prostate-specific antigen reductions in 47.6% of patients at 12 weeks and 87.4% at 48 weeks, compared to 37.7% and 74.9%, respectively, for standard care alone, Novartis said.

Regulatory submissions for the increased use have been filed in the US, China, and Japan, with initial decisions expected in H2, it added.