- Novartis announced FDA approval of Pluvicto in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer.
- The expanded indication allows Pluvicto use across all stages of PSMA-positive metastatic prostate cancer and nearly doubles its eligible patient population.
- In the Phase III PSMAddition trial, Pluvicto plus standard of care reduced the risk of progression or death by 28% at the primary analysis versus standard of care alone.
Quotes
“Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients.”
“This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention.”