Clinical-stage oncology company Jacobio Pharma’s in-house KRAS G12C inhibitor glecirasib has been granted breakthrough therapy designation (BTD), by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment.
This BTD was granted based on the clinical efficacy and safety data from ongoing gleciracib clinical trials. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients.
Glecirasib’s pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The pivotal clinical trial will evaluate the efficacy and safety of single agent glecirasib in KRAS G12C-mutated locally advanced or metastatic pancreatic cancer patients who have progressed on frontline standard care treatment. This is a multi-center, single-arm, open-label study.
Pancreatic cancer is a highly aggressive malignancy and with a limited effective treatment currently. The five-year overall survival rate is only 5%.
Pancreatic cancer is glecirasib’s second BTD indication in China. In December 2022, gleciracib was granted BTD for the second line setting and beyond of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation.
