Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan).
The radiopharmaceutical medication, from Novartis company Advanced Accelerator Applications USA, Inc., was approved on March 23 for treating adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). More specifically, the treatment is approved for such patients who have received taxane-based chemotherapy and androgen receptor pathway inhibition treatment.
At the same time, the FDA also approved a radioactive diagnostic agent— Locametz—for positron emission tomography of PSMA-positive lesions. This agent is the first to receive approval for selecting patients for treatment with a radioligand therapeutic agent, according to the FDA.
In a statement announcing the approvals, the FDA said that patients should be chosen for treatment with Pluvicto using either Locametz or “another approved PSMA-11 imaging agent based on PSMA expression in tumors.”
Pluvicto’s efficacy was determined in a randomized, multicenter, open-label trial that explored the treatment’s use alone and in combination with best standard of care. According to the FDA release, the results of the trial showed “a statistically significant improvement in the primary endpoints of overall survival and radiographic progression-free survival” for patients.
More information can be found on the FDA website.