China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations and for NSCLC with previous EGFR-TKI treatment and T790M mutation positive.
Drug Background and Innovation
Ameile is the world’s second innovative third-generation EGFR-TKI after AstraZeneca’s Tagrisso (osimertinib). It received market approval in China in March 2020 for T790M-mutated locally advanced or metastatic NSCLC following first-line EGFR-TKI treatment and for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation positive in December 2021.
Clinical Trial Results
The filing is based on the results of the Phase III AENEAS study, which compared Ameile to gefitinib in first-line EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC. The study, involving over 400 participants, met its primary endpoint, demonstrating significantly prolonged progression-free survival with an improved safety profile.-Fineline Info & Tech
