Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutation.
Furmonertinib: Development and Collaboration
Furmonertinib, discovered in-house by Allist, is an irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor. The drug is being co-developed in territories outside of Greater China with ArriVent under a deal signed in 2021. This collaboration aims to expand the reach and impact of furmonertinib in treating NSCLC globally.
Regulatory Milestones and Reimbursement
Furmonertinib was first approved in China in March 2021 to treat patients with locally advanced or metastatic NSCLC that is EGFR T790M mutation-positive and has progressed following treatment with an earlier generation EGFR-targeted TKI. It further gained approval for use in first-line locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) replacement mutation in June 2022. Both indications are included in the National Reimbursement Drug List (NRDL), enhancing patient access to this innovative therapy.-Fineline Info & Tech
