Durable Response Rate to beat at 36 monthsCurrently Adstiladrin is the best available FDA approved treatment for high-grade BCG-unresponsive NMIBC (excluding cystectomy)
If the FDA needs to compare the durable CRR of Ruvidar PDT with the best available alternative then:
the 36 month CRR that needs to be beaten is 14% (14 out of the 103 patients in Adstiladrin's CIS cohort have a CR at 3 years)
Ruvidar PDT should do considerably better than this given it's
450 day optimized CRR of 38% (
Adstiladrin achieved a
12 month CRR of only 24%) and the tendency of the durable response of the Ruvidar treatment to endure after maintaining a CR for one year.
Also, as we know, Adstiladrin patients require many more treatments to maintain their complete response.
Three-Year Follow-up Data in BCG-Unresponsive NMIBC Show Durable Response to Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) in Two Patient Cohorts Published: Apr 08, 2024