Prostate Cancer Treatment Pluvicto Currently in Shortage
Pluvicto is indicated for patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.
Pluvicto is indicated for patients with PSMA-positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.
The sNDA is supported by data from the phase 3 PROpel trial which included adults with mCRPC in the first-line setting.
The approval was based on data from the phase 3 ARASENS trial.
At a median follow-up of 12 weeks, results showed that the composite response rate was 23%.
The PRESIDE trial included 687 chemotherapy-naïve patients with mCRPC who had progressive disease while on androgen deprivation therapy or following bilateral orchiectomy.
The analysis included 4919 patients, of which 19.7% (n=969) had received a lipophilic statin and 9.2% (n=452) had received a hydrophilic statin.
Following a planned interim analysis, the decision to halt the trial was made after a review of data by an independent Data Monitoring Committee.
Study authors analyzed a total of 46 Black men with advanced prostate cancer enrolled in the phase 3 HERO study.
The phase 3 MAGNITUDE study assessed niraparib in combination with abiraterone acetate plus prednisone in patients with mCRPC with or without alterations in homologous recombination repair associated genes.
A midlife PSA value above the 90th percentile was associated with greater risk of total and aggressive prostate cancer in black men.