EMA 同意某在研药物非小细胞肺癌儿科研究计划

EMA/PE/0000240204

AI 导读

EMA 对活性物质 (12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10。

正文 · 原文

Key facts

Active substance: (12m)-(1s,2s)-n-((63s,4s,z)-11-ethyl-12-(2-((s)-1-methoxyethyl)-5-(4-methylpiperazin-1-yl)pyridin-3-yl)-10,10-dimethyl-5,7-dioxo-61,62,63,64,65,66-hexahydro-11h-8-oxa-2(4,2)-thiazola-1(5,3)-indola-6(1,3)-pyridazinacycloundecaphane-4-yl)-2-methylcyclopropane-1-carboxamide
Therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Decision number: EMA/PE/0000240204
PIP number: EMA/PE/0000240204
Pharmaceutical form(s): All pharmaceutical forms
Condition(s) / indication(s): Treatment of non-small cell lung cancer
Route(s) of administration: All routes of administration
Contact for public enquiries
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date: 10/07/2025
Compliance check done: No

来源：EMA What's New · ema.europa.eu