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. The gold standard of business intelligence.
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.
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Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form In addition to its monotherapy application, fulzerasib is being investigated in combination with EGFR inhibitors, which may offer a synergist.