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Jacobio Pharma's Glecirasib, KRAS G12C Inhibitor, Receives China CDE's Breakthrough Therapy Designation

Tuesday, August 08, 2023

Jacobio Pharma announced that KRAS G12C inhibitor glecirasib has been granted breakthrough therapy designation (BTD) by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for pancreatic cancer patients who possess a KRAS G12C mutation and have experienced disease progression after their initial standard care treatment.

Glecirasib is a type of targeted therapy known as a KRAS G12C inhibitor. The ongoing Phase I/II clinical trials of glecirasib in China, the United States, and Europe are aimed at evaluating its efficacy and safety in patients with advanced solid tumours that harbour the KRAS G12C mutation.

The pivotal clinical trial will focus on assessing the effectiveness and safety of glecirasib as a single-agent treatment in patients with locally advanced or metastatic pancreatic cancer who carry the KRAS G12C mutation and have experienced disease progression after receiving frontline standard care treatment.

If the results of these clinical trials demonstrate promising outcomes, it can lead to the approval of glecirasib as a targeted therapy option for patients with KRAS G12C-mutated cancers, potentially providing with a new treatment option.

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