The U.S. FDA has approved Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan), a new radioactive therapeutic agent from Novartis, to treat prostate cancer. It has also approved an accompanying new indication for Locametz® (kit for the preparation of gallium Ga 68 gozetotide injection), an imaging agent also made by Novartis and first FDA approved in 2020.

• Pluvicto is indicated to treat adults who have prostate-specific membrane antigen (PSMA) positive metastatic castration-resistant prostate cancer. Patients must have undergone treatment with androgen receptor pathway inhibition and taxane-based chemotherapy.
• Locametz received a new indication for positron emission tomography (PET) of PSMA-positive lesions for selection of male patients who have metastatic prostate cancer and for whom Pluvicto PSMA-directed therapy is indicated.
• Both Pluvicto and Locametz should be used by or under the control of healthcare providers qualified in proper handling of radiopharmaceuticals. Recommended dosing is as follows:
  • Pluvicto: 7.4 GBq (200 mCi) once every six weeks, administered via intravenous injection or infusion, for up to six doses or until disease progression or unacceptable toxicity occur.
  • Locametz: 111 MBq to 259 MBq (3 mCi to 7 mCi) radioactivity, administered as a slow intravenous injection.
• Novartis has launched Pluvicto at a wholesale acquisition cost (WAC) of $42,500 per vial.