FDA Grants Orphan Drug Designation to Certepetide in Cholangiocarcinoma - OncLive
FDA grants orphan drug designation to certepetide for cholangiocarcinoma. Certepetide is being evaluated in phase 2 BOLSTER trial with SOC therapies. It enhances drug delivery and tumor microenvironment modulation. BOLSTER trial includes first- and second-line treatments with certepetide. Certepetide also has ODD for malignant glioma, osteosarcoma, and pancreatic cancer.
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FDA grants orphan drug designation to certepetide for cholangiocarcinoma. Certepetide is being evaluated in phase 2 BOLSTER trial with SOC therapies. It enhances drug delivery and tumor microenvironment modulation. BOLSTER trial includes first- and second-line treatments with certepetide. Certepetide also has ODD for malignant glioma, osteosarcoma, and pancreatic cancer.
The FDA granted orphan drug designation to certepetide for treating cholangiocarcinoma, an investigational agent enhancing anticancer drug penetration into tumors. Certepetide is being studied in the phase 2a BOLSTER trial (NCT05712356), with 80 patients randomized into four arms, focusing on adverse event incidence.