WeChat· 药事纵横·· 11 hours agoPickScore71
FDA Approves Anktiva for BCG-Unresponsive High-Grade Papillary-Only NMIBC
In brief
The FDA has approved Anktiva for patients with BCG-unresponsive, high-grade papillary-only non-muscle invasive bladder cancer (NMIBC), making it the first approved therapy for this population. The source says the approval marks a new FDA approach to evaluating therapies for BCG-unresponsive NMIBC, and notes that CIS is always high-grade while papillary tumors can be low-grade or high-grade.
Why it matters
First approval under the FDA's new evaluation approach for BCG-unresponsive NMIBC therapies, informative for future reviews in the same indication.
Source: WeChat · mp.weixin.qq.com