Vol 53 No 02

“The key here is I don’t believe that testosterone increases the risk of prostate cancer progression or biochemical recurrence," says Mohit Khera, MD, MBA, MPH.

"Please note that although this starts out as a balloon rather than just the injection of a biodegradable product, this device is actually fully biodegradable and is absorbed within 6 months of insertion," write Jonathan Rubenstein, MD, and Mark Painter.

At 25 weeks, FACT-P total score remained comparable between the arms.

"The increasing expenses associated with bladder cancer treatment highlight wider issues regarding the sustainability of health care expenditures in the US," writes Michael S. Cookson, MD, MMHC, FACS.

The J-code became effective on January 1, 2025.

The BLA for TLX250-CDx was initially submitted to the FDA in June 2024.

The approval is supported by data from the phase 3 CheckMate-67T trial.

The SURE procedure also demonstrated significantly better outcomes on the study’s secondary end points of stone clearance and residual stone volume.

The approval of vibegron is supported by data from the phase 3 COURAGE trial.

From baseline to 1 year, the Ki-67 index decreased in the dietary intervention cohort by 15% and increased in the control cohort by 24%.

Specifically, 90% of patients in the HIFU arm vs 86% of patients in the radical prostatectomy arm were free from subsequent definitive treatment at 30 months.

CR rate was 98% (39/40) at 3 months, 94% at 6 months (34/36), and 81% at 12 months (21/26).

The overall complete response rate was 74.5% (95% CI, 65.4%-82.4%).

Anemia was the most frequently observed any-cause AE and was seen in 485 (84.2%) patients.

Overall median time from first documented biomarker test date to index date was 5.5 months.