FDA green-lights Ra 223 dichloride for prostate cancer

The FDA approved radium Ra 223 dichloride (Xofigo Injection, Bayer HealthCare Pharmaceuticals) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.  

The alpha-particle emitting radiotherapy mimics calcium and forms complexes with hydroxyapatite at bone metastases.

The FDA based its approval on a double-blind, randomized, placebo-controlled trial in patients with metastatic castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. The primary endpoint of the study was overall survival.

A total of 541 patients were treated with Xofigo plus best standard of care; another 268 were allocated to matching placebo plus best standard of care. “Best standard of care included local radiotherapy, corticosteroids, anti-androgens, estrogens, estramustine or ketoconazole,” the FDA explained in a release. All patients were to continue androgen deprivation therapy.  

At interim analysis, median overall survival in the Xofigo arm showed a statistically significant improvement at 14 months vs. 11.2 months in the placebo arm. The Xofigo cohort also demonstrated a delay in time-to-first symptomatic skeletal event compared with the placebo arm.

Around the web

RBMA President Peter Moffatt discusses some of the biggest obstacles facing the specialty in the new year. 

Deepak Bhatt, MD, director of the Mount Sinai Fuster Heart Hospital and principal investigator of the TRANSFORM trial, explains an emerging technique for cardiac screening: combining coronary CT angiography with artificial intelligence for plaque analysis to create an approach similar to mammography.

A total of 16 cardiology practices from 12 states settled with the DOJ to resolve allegations they overbilled Medicare for imaging agents used to diagnose cardiovascular disease.