FDA has granted Orphan Drug Designation (ODD) to Lisata Therapeutics, certepetide for treating cholangiocarcinoma.
Certepetide is being evaluated in the Phase 2a BOLSTER trial for first- and second-line cholangiocarcinoma treatment, and is being evaluated alongside standard-of-care therapies.
Kristen K. Buck, M.D., EVP of R&D and CMO of Lisata emphasized cholangiocarcinoma as a rare and aggressive form of cancer that presents a significant challenge for patients due to limited treatment options, especially after initial therapy.
She acknowledged the importance of progress in this field by recognizing that receiving ODD for their investigational product, certepetide, was a significant milestone in addressing the unmet needs of cholangiocarcinoma patients.
Dr. Buck further offered that this designation brings Lisata one step closer to providing innovative and much-needed treatment options for these patients.
Source: Lisata Therapeutics’ Certepetide Granted FDA Orphan Drug Designation for the Treatment of Cholangiocarcinoma
https://ir.lisata.com/news-releases/news-release-details/lisata-therapeutics-certepetide-granted-fda-orphan-drug
