Firmonertinib is an oral, brain penetrative, and mutation selective EGFR inhibitor. It targets multiple EGFR mutations, including exon 20 insertion and T790M resistance mutation. Firmonertinib is being developed as a first-line treatment for advanced non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion.
indication
Used for the treatment of non-small cell lung cancer (NSCLC) with EGFR sensitive mutations and EGFRT790M resistant mutations.
effectiveness
Furmonertinib, with the R&D code AST2818 and formerly known as alflutinib, is the third representative epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).
On March 3, 2021, the official website of the National Administration of China announced that Alex Pharmaceuticals' Fumatinib Mesylate has been approved by the NMPA for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFRT790M mutation positivity.
On June 28, 2022, the new indication for Fumatinib has been approved by the National Medical Products Administration (NMPA) of China for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) replacement mutation.
adverse reaction
Common adverse reactions include elevated transaminase levels, upper respiratory tract infections, and coughing (with an incidence rate of around 15%). The incidence of diarrhea is relatively low (6.0%), with diarrhea of grade 3 or above accounting for 0.4%. 19.1% of patients experienced grade 3-5 adverse events, with the most common being elevated levels of gamma glutamyl transferase (n=4).
