The FDA has also approved Locametz ® (kit for the preparation of gallium Ga 68 gozetotide injection) 2. Pluvicto is expected to be available to physicians and patients within weeks. Pluvicto is the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle) 1. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.” “The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” said Oliver Sartor, MD, Medical Director at Tulane Cancer Center. These patients have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy) 1. 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 diseaseīasel, MaNovartis announced today that the US Food and Drug Administration (FDA) approved Pluvicto TM (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) for the treatment of adult patients with a certain type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has spread to other parts of the body (metastatic) 1.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).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 death 1 both alternate primary endpoints of overall survival and radiographic progression free survival were met 1.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 also approved complementary diagnostic imaging agent, Locametz ®, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions 2.
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