> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Prostate Cancer Drug Gets ‘Fast Track’
- URL: https://www.fdaweb.com/prostate-cancer-drug-gets-fast-track/
- Published: 2023-04-24T12:00:00.000Z
- Updated: 2026-09-14T18:27:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154287

FDA has granted Lantheus Holdings and Point Biopharma Global a fast track designation for 177Lu-PNT2002 for treating metastatic castration resistant prostate cancer (mCRPC). The companies say the radiopharmaceutical therapy combines a prostate specific membrane antigen (PSMA)-targeted ligand, PSMA-I&T, with a beta-emitting radioisotope.

The therapy is currently being assessed in the Phase 3 SPLASH trial in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor therapy and refuse, or are not eligible for, chemotherapy. The primary endpoint is radiographic progression-free survival, and key secondary endpoints include overall survival, overall response rate, and duration of response, the companies say.