The National Medical Products Administration (NMPA) of China has granted approval for GenFleet Therapeutics’ fulzerasib for advanced non-small cell lung cancer (NSCLC) harbouring KRAS G12C mutation.
The treatment is indicated for patients who have received a minimum of one systemic therapy previously.
Last year, the regulator granted priority review for the New Drug Application (NDA) seeking approval for the asset.
Previously, fulzerasib also received two breakthrough therapy designations for its potential in treating advanced KRAS G12C-mutant NSCLC and colorectal cancer patients.
The approval was grounded on the results from a single-arm registrational study, which showed that fulzerasib was generally well-tolerated and exhibited promising antitumor activity.
This study reported a 49.1% objective response rate and a 90.5% disease control rate, with the median progression-free survival reaching 9.7 months.
In addition to its monotherapy application, fulzerasib is being investigated in combination with EGFR inhibitors, which may offer a synergistic effect and the possibility of first-line treatment.
A European study initiated last year is currently exploring this combination, with preliminary Phase II data demonstrating an 81.8% objective response rate.
Discovered by GenFleet Therapeutics, fulzerasib is an orally active KRAS G12C inhibitor.
In September 2021, Innovent and GenFleet signed a license agreement to develop and commercialise fulzerasib in China, including Hong Kong, Macau, and Taiwan.
This agreement also includes option-in rights for global development and commercialisation.
GenFleet Therapeutics chief medical officer Yu Wang said: “Initiated in 2018, the fulzerasib’s development has been moving forward rapidly and yielded positive results.
“Given the high G12C prevalence among advanced NSCLC patients in western countries, GenFleet has embarked on the KROCUS study in Europe, a pioneering trial of first-line therapy integrating KRAS and EGFR inhibitors.
“In specific patient populations, the KROCUS study has demonstrated efficacy and safety potentially comparable or even superior to immunotherapy combined with chemotherapy, positioning the fulzerasib/cetuximab combination as a potentially novel first-line SOC for G12C-mutated NSCLC patients.”
