Posted by Michael Wonder on 24 Feb 2026
Artios receives US FDA fast track designation for DNA polymerase theta inhibitor ART6043 for treatment of gBRCA-mutated HER2 negative breast cancer
23 February 2026 - Artios Pharma today announced that the US FDA granted fast track designation to its potentially first in class DNA polymerase theta inhibitor, ART6043, in combination with the PARP inhibitor, olaparib, for the treatment of adult patients with germline BRCA mutated HER2 negative locally advanced or metastatic breast cancer who have received no prior treatment with a PARP inhibitor.
The designation was granted based on data from the ongoing, first-in-human, Phase 1/2a study, evaluating ART6043 in combination with olaparib in patients with advanced solid tumours harbouring mutations in DDR pathways, including germline BRCA mutated, HER2 negative breast cancer.
