The majority of people with advanced EGFR-mutant non-small cell lung cancer (NSCLC) receiving first-line osimertinib ...
The decision to submit a new BLA for EGFR-mutated NSCLC and withdraw the previously submitted BLA for nonsquamous NSCLC was informed by feedback from the US Food and Drug Administration (FDA). The new ...
抗表皮生长因子受体(EGFR)单抗是重要的肿瘤治疗药物,通过特异性抑制 EGFR 下游信号通路发挥抗肿瘤效应,在 RAS/BRAF 野生型的转移性结直肠癌(mCRC)、非小细胞肺癌(NSCLC)中应用广泛。然而,有研究显示超过 80% 的患者使用抗 ...
Presented preclinical data further supporting the potential best-in-class profile of ORIC-114 to treat EGFR exon 20 insertions and other atypical ...
“Notably, the FDA also confirmed that ProKidney could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel. We look forward to continuing our dialogue ...
目前,EGFR-TKI单药靶向治疗是EGFR敏感突变阳性的晚期非小细胞肺癌(NSCLC)患者一线治疗的标准治疗方案,但随着FLAURA2和MARIPOSA研究结果的公布,EGFR敏感突变阳性晚期NSCLC患者更适合靶向联合治疗还是靶向单药治疗,成为现 ...
Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...
10月31日,迪哲医药发布了2024年的三季度业绩。今年前三季度,迪哲医药营收达到3.38亿元,同比增长743.97%,公司亏损缩减32.63%,达到5.58亿元。
A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non ...
Fabry Disease Program: Achieved alignment with FDA for accelerated approval pathway, reducing approval time by three years.