Posted by Michael Wonder on 28 Aug 2025
D3 Bio announces FDA breakthrough therapy designation and orphan drug designation for D3S-001 for the treatment of patients with KRAS G12C mutated cancers
28 August 2025 - D3 Bio today announced that the US FDA has granted a breakthrough therapy designation to D3S-001, the company's next generation KRAS G12C selective inhibitor, for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor.
Additionally, D3S-001 has been granted orphan drug designation for the treatment of adult patients with KRAS G12C mutated locally advanced or metastatic colorectal cancer.
