来源:FDA Label 安全性方面,avapritinib治疗最常见的不良反应包括水肿、恶心、疲劳、认知功能损伤、呕吐、食欲下降、腹泻等。 2017年6月,avapritinib获美国食品和药物管理局(FDA)授予的突破性疗法认定,用于治疗携带PDGFRα D842V突变的不可切除或转移性胃肠道间质瘤患者。此前,avapritinib已获FDA授予的孤儿药...
Avapritinib 是一种激酶抑制剂,已获美国 FDA 批准,用于治疗携带 PDGFRA 外显子 18 突变(包括 PDGFRA D842V 突变)的不可切除或转移性胃肠间质瘤(GIST)成人患者。AYVAKIT 是首个获批用于治疗基因组定义的 GIST 患者精准疗法,也是唯一针对 PDGFRA 外显子 18 突变型 GIST 的高效治疗药物。FDA 已授予了 avaprit...
AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and mast ce...
Jr. Properties of FDA-approved small molecule protein kinase inhibitors: a 2021 update. Pharm. Res. 165, 105463 (2021). 22. Kissova, M., Maga, G. & Crespan, E. The human tyrosine kinase Kit and its gatekeeper mutant T670I, show different kinetic properties: implications for drug ...
February 10, 2025 · 2 min read · Heather McKenzie Infectious disease AbbVie Gets FDA Approval for New Antibiotic in the Face of Rising Resistance February 10, 2025 · 2 min read · Dan Samorodnitsky Lym...
-A test approved by the US FDA for the detection of exon 18 mutations is not currently available. Use: For the treatment of unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations ...
AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with Advanced SM, including aggressive SM (ASM), SM with an associated hematological neoplasm (SM-AHN) and...
In the open-label, multicenter phase 1/2 trial designed to evaluate avapritinib in patients with unresectable or metastatic GIST, the median duration of treatment was 25.4 weeks. In patients with PDGFRA D842V-mutant GIST, the overall response rate (ORR) was 75%, including 15 patients w...
The US Food and Drug Administration (US FDA) has approved Ayvakit for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. This medicine is approved by the European Commission under the brand name...