Shanghai-based Allist Pharmaceuticals Inc. (SHA: 688578) announced that it has received another indication approval from the National Medical Products Administration (NMPA) for furmonertinib. The third-generation epidermal growth factor receptor (EGFR) inhibitor is now approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutation.
Drug Profile
Allist’s furmonertinib is a Category 1 innovative product that first received conditional market approval from the NMPA in March 2021. It was approved for use in locally advanced or metastatic NSCLC that is EGFR T790M mutation-positive and has progressed following treatment with an earlier-generation EGFR-targeted TKI.
Clinical Trial Results
The approval is based on the results of the national multi-center, randomized controlled, double-blind Phase III regulatory FURLONG study. The study showed that compared with gefitinib (Iressa) in the control group, furmonertinib significantly prolonged progression-free survival (PFS) as a first-line treatment for EGFR-sensitive mutated advanced NSCLC, reducing the risk of disease progression or death by 56%. Despite the longer exposure time, the incidence of furmonertinib ≥ grade 3 adverse reactions was lower than in the control group (11% vs 18%).-Fineline Info & Tech
