Jacobio Pharma Receives Centre for Drug Evaluation Approval for Pivotal Study of Glecirasib in Pancreatic Cancer
Wednesday, July 05, 2023
Jacobio Pharma announced the approval of novel KRAS G12C inhibitor, glecirasib, for a pivotal study in pancreatic cancer by the Centre for Drug Evaluation (CDE).
This approval marks an important milestone as it represents the first global registrational clinical study for KRAS G12C in the treatment of pancreatic cancer.
A pivotal clinical trial has been approved in China to assess the effectiveness and safety of Glecirasib as a standalone treatment for pancreatic cancer patients who have already undergone second-line treatment or higher specifically for individuals with a KRAS G12C mutation in pancreatic cancer.
The study results obtained from this pivotal trial will likely be used to support the submission of a New Drug Application (NDA) for Glecirasib as a potential treatment for pancreatic cancer with KRAS G12C mutation.
Glecirasib is a novel KRAS G12C inhibitor, which specifically targets the KRAS G12C mutation found in certain solid tumours. These clinical trials are being conducted in China, the United States, and Europe, and their purpose is to evaluate the safety, tolerability, and efficacy of glecirasib in different patient populations with advanced solid tumours carrying the KRAS G12C mutation.
