NMPA of China Accepted and Granted Priority Review Designation to the NDA for Glecirasib
“The NDA acceptance and Priority Review designation are based on the results from a Phase II pivotal clinical trial (NCT05276726) intended to evaluate the efficacy and safety of glecirasib as a single agent for the treatment of NSCLC patients with KRAS G12C mutation. According to the regulations of the NMPA, the review time for NDA included in the Priority Review designation is within 130 working days, which will further accelerate the approval of glecirasib and meet unmet clinical needs.”
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