Deadline for Novartis, page-19

Don't forget, Novartis have always been keeping their options open in relation to SR-GVHD .... let's hope that they continue that logic and proceed with the Mesoblast deal ?

I found this interesting in the FDA Calendar - I guess if I were Incyte I would be rushing this through as well so they didn't have to compete against Remestemcel-L if it got AA ?

Have a great weekend MSB'ers

https://www.fdatracker.com/fda-calendar/

INCY INCYTE PDUFA
WhenTuesday, Jun 22, 2021
Description2021-06-22 The Prescription Drug User Fee Act (PDUFA) target action date for Jakafi in steroid-refractory chronic GVHD is June 22, 2021.

https://www.businesswire.com/news/h...tients-with-Chronic-Graft-Versus-Host-Disease

About REACH3

REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte, is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory chronic GVHD.

The primary endpoint is overall response rate (ORR) at Week 24 (i.e., Cycle 7, Day 1), defined as the percentage of participants demonstrating a complete or partial response. Key secondary endpoints include failure-free survival (FFS) and change in the modified Lee Symptom Scale (mLSS) score at Week 24. Other secondary endpoints include best overall response (BOR), duration of response (DoR), overall survival (OS), and safety.

For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.


https://clinicaltrials.gov/ct2/show/NCT03112603?term=NCT03112603&draw=2&rank=1