Core Points - Diger Pharma announced that its new drug application for ZEGFROVY® (generic name: suvoritinib tablets) has been officially approved by the U.S. Food and Drug Administration (FDA) [1] - The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy and have confirmed epidermal growth factor receptor (EGFR) exon 20 insertion mutations [1] Company Summary - Diger Pharma's ZEGFROVY® is now FDA-approved, marking a significant milestone for the company in the oncology market [1] - The approval targets a specific patient population, enhancing the company's portfolio in precision medicine [1] Industry Summary - The approval of ZEGFROVY® reflects ongoing advancements in targeted therapies for NSCLC, particularly for patients with specific genetic mutations [1] - This development may influence competitive dynamics within the oncology sector, as companies focus on personalized treatment options [1]
迪哲医药舒沃哲®获FDA加速批准上市,系全球首款在美获批的EGFR exon20ins非小细胞肺癌国创新药