- FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions2
- Metastatic prostate cancer has a 5-year survival rate of less than 30%3; mCRPC patients who progress on multiple lines of therapy have limited treatment options
- FDA approval was based on pivotal Phase III VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of overall survival and radiographic progression free survival were met1
- Novartis is committed to reimagining medicine in prostate cancer with targeted radioligand therapy – a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)
- Two pivotal Phase III studies evaluating Pluvicto in earlier lines of treatment for metastatic prostate cancer are underway, with a goal to move into earlier stages of disease