CellBion seeks conditional approval for prostate cancer treatment candidate 177Lu-pocuvotide

CAR-T Digest - August 2020

30 December 2025: CellBion seeks conditional approval for prostate cancer treatment candidate 177Lu-pocuvotide

CellBion completed submission of a conditional approval application on December 30 to the Ministry of Food and Drug Safety (MFDS) for 177Lu-pocuvotide, a radiotherapeutic candidate for metastatic castration-resistant prostate cancer (mCRPC), supported by a Phase 2 Clinical Study Report received on December 12
The company is leveraging Korea’s conditional approval pathway, which allows market authorization based on Phase 2 data, to accelerate access for patients with rare and intractable diseases and enable earlier commercialization
177Lu-pocuvotide is a next-generation PSMA-targeted radiotherapy that delivers lutetium-177 directly to prostate cancer cells. Phase 2 results showed an objective response rate (ORR) of 35.9% with substantially lower treatment-related adverse events
The efficacy was reported as comparable to or exceeding that of the market-leading competitor from Novartis, positioning 177Lu-pocuvotide as a potentially meaningful new option for advanced prostate cancer patients with limited alternatives
Detailed Phase 2 data will be presented at the ASCO Genitourinary Cancers Symposium (ASCO-GU) in February 2026, while CellBion expects approval and commercialization in Korea within a year, alongside GMP capacity expansion and nationwide logistics setup to ensure immediate supply upon approval