![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Radioligand Prostate Therapy Shows Promise in Late-Stage Trial
Radioligand Prostate Therapy Shows Promise in Late-Stage Trial
March 24, 2021
Novartis has announced positive results from a phase 3 trial of its radioligand therapy, Lu-PSMA-617, for treatment of progressive prostate-specific membrane antigen (PMSA)-positive metastatic castration-resistant prostate cancer.
Radioligand therapy delivers targeted radiation to tumors in a way that limits damage to the surrounding tissue. A radioligand is made of two parts, a ligand — an ion or molecule — that binds with specific cancer cell molecules and a radioisotope that emits radiation to kill the cells.
Lu-PSMA-617 therapy significantly improved overall survival and radiographic progression-free survival, Novartis said, adding that the positive results will support applications for approval in the U.S. and EU.
Upcoming Events
-
21Oct