The Center for Drug Evaluation (CDE) in China has indicated on its website that Allist Pharmaceuticals Co., Ltd, a Shanghai-based biotech firm, has received breakthrough therapy designations (BTDs) for its epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) furmonertinib and for Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody drug conjugate (ADC) co-developed by AstraZeneca and Daiichi Sankyo. Both drugs are under development for the treatment of non-small cell lung cancer (NSCLC).
Furmonertinib, discovered in-house by Allist, is an irreversible, selective, third-generation EGFR TKI co-developed with ArriVent in territories outside of Greater China under a 2021 deal. Initially approved in China in March 2021 for 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, furmonertinib later 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). In October last year, the drug was awarded BTD status in the US for the treatment of previously untreated, locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation. The current BTD status in China is related to first-line locally advanced or metastatic NSCLC with EGFR 20 exon insertion mutation.
Enhertu, first approved in China in February 2023 for the treatment of unresectable or metastatic HER2 positive adult breast cancer patients who have previously received one or more anti-HER2 drugs, earned further approval in July last year for use as a monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer in previously treated patients with metastatic disease or those who have disease recurrence within six months of completing adjuvant chemotherapy. The current BTD status is indicated for the treatment of unresectable or metastatic NSCLC with activated HER2 (ERBB2) mutations that has previously received at least one systemic treatment.- Flcube.com
