The Center for Drug Evaluation (CDE) has indicated that Innovent Biologics’s (HKG: 1801) Category 1 chemical drug, GFH925, is set to receive priority review status for the treatment of advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation in patients who have received at least one systemic treatment. This priority status underscores the drug’s breakthrough therapy designation (BTD) and its eligibility for conditional approval.
GFH925: Development and Potential
GFH925, a KRAS G12C inhibitor developed by GenFleet Therapeutics Inc., has demonstrated best-in-class potential in pre-clinical studies, effectively inhibiting the growth of numerous tumor cell lines carrying the KRAS G12C mutation. Innovent Biologics secured exclusive development and commercialization rights to the drug in Greater China through a USD 312 million deal with GenFleet in September 2021.
Previous Recognition and Market Reach
The drug previously achieved BTD status in December of the previous year for treating KRASG12C mutant advanced NSCLC in patients who had been previously treated with at least one systemic therapy. This recognition highlights the potential of GFH925 to address a significant unmet medical need in the treatment of NSCLC.-Fineline Info & Tech
