Targeted Oncology, Sarah Karlovitch, June 17, 2021
The FDA has granted Breakthrough therapy designation to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
The Breakthrough therapy designation is based on results of the randomized, parallel assignment phase 3 VISION trial (NCT03511664), designed to enroll 831 participants and an estimated completion date of June 2022.