On March 23, 2022, the United States Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, also known as 177Lu-PSMA-617) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. The recommended 177Lu-PSMA-617 dose is 7.4 gigabecquerels (GBq; 200 mCi) intravenously every 6 weeks for up to 6 doses, or until disease progression or unacceptable toxicity. The FDA granted traditional approval based on VISION (NCT03511664), which was a randomized (2:1), multicenter, open-label trial that assessed the efficacy and safety of 177Lu-PSMA-617 plus best standard of care (BSoC) (n=551) or BSoC alone (n=280) in men with progressive, PSMA-positive mCRPC. Patients were required to have received ≥1 androgen receptor pathway inhibitor, and 1 or 2 prior taxane-based chemotherapy regimens. There was a statistically significant and clinically meaningful improvement in overall survival (OS) with a median OS of 15.3 months in the 177Lu-PSMA-617 plus BSoC arm and 11.3 months in the BSoC arm, respectively (Hazard ratio: 0.62, 95% CI: 0.52, 0.74, p<0.001). The most common adverse reactions (≥20%) occurring at a higher incidence in patients receiving 177Lu-PSMA-617 were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. The most common laboratory abnormalities that worsened from baseline in ≥30% of patients receiving 177Lu-PSMA-617 were decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium. This article summarizes the FDA review of data supporting traditional approval of 177Lu-PSMA-617 for this indication.

In MgF2:Mn2+, Eu2+ phosphors, the x-ray excited luminescence from Eu2+ is decreased while the emission from Mn2+ is increased in intensity with the increase of x-ray dose. In MgF2:Mn2+, the luminescence is also increased, and in MgF2:Eu2+, the emission of Eu2+ is also decreased in intensity with the increase of x-ray dose. However, the intensity changes with x-ray dose in the singly doped MgF2:Mn2+ and MgF2:Eu2+ phosphors are much less than those in the doubly doped MgF2:Mn2+, Eu2+ phosphors. The increase of Mn2+ emission in intensity is likely due to the breakdown of the forbidden transition by the defects created by x-ray irradiation. No conversion of Eu2+ ions to Eu3+ ions was observed in MgF2:Eu2+ phosphors during x-ray irradiation. The decrease of Eu2+ emission in intensity in MgF2:Mn2+, Eu2+ must be closely related to the interaction and the energy transfer to Mn2+ ions. The phenomenon observed is potentially interesting for the practical applications for radiation detection, as utilizing the ratio of the two emissions from Mn2+ and Eu2+ for radiation detection is more sensitive and more reliable than using emission intensity change only.

In the photoluminescence (PL) of BaFBr:Eu2+,Eu3+, the emissions of Eu2+, carrier electron-hole (e-h) recombination, and Eu3+ are observed, while in the photostimulated luminescence (PSL) only the emission of Eu2+ is exhibited. This disappearance of e-h recombination in PSL is considered to be caused by carrier migration during photo-stimulation.