mp.weixin.qq.com·· 5 hours agoPickScore84
Imprecise Label in the Precision Medicine Era: FDA Approval of Daraxonrasib
In brief
The FDA has approved the pan-RAS inhibitor daraxonrasib for previously treated metastatic pancreatic adenocarcinoma. The RASolute 302 trial showed a median overall survival of 13.2 months (HR 0.40), but the label's extension to patients "not suitable for multi-drug systemic therapy" has drawn controversy.
Why it matters
The article analyzes the daraxonrasib label controversy, arguing the vague wording is regulatory wisdom to cover real-world frail patients.
Source: mp.weixin.qq.com · mp.weixin.qq.com