Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in patients with epidermal growth factor receptor (EGFR) mutation-positive non-squamous non-small cell lung cancer (NSCLC) that has metastasized to the brain.
Furmonertinib, an in-house discovery of Allist, is an irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor. It is co-developed in regions outside of Greater China in partnership with ArriVent, following a deal established in 2021. Initially approved in China in March 2021 to treat patients with locally advanced or metastatic NSCLC that harbors an EGFR T790M mutation and has progressed after treatment with an earlier EGFR-targeted TKI, furmonertinib subsequently received approval for first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation in June 2022. The drug is currently under Phase III investigation for use as adjuvant therapy in NSCLC with sensitive EGFR mutations and as a first-line treatment for NSCLC with rare EGFR mutations. Notably, furmonertinib has previously been granted breakthrough therapy designation (BTD) in both the US and China for the treatment of NSCLC with EGFR 20 exon insertion mutations.- Flcube.com
