Posted by Michael Wonder on 31 Oct 2017
Janssen announces Imbruvica (ibrutinib) as the first approved treatment for chronic graft-versus-host disease granted by Health Canada priority review
30 October 2017 - Approval provides a much-needed option for patients who develop this life-threatening condition following stem cell transplant.
Janssen announced today that following priority review, Health Canada has approved Imbruvica (ibrutinib), an oral, once-daily targeted therapy, for the treatment of patients with steroid dependent or refractory chronic graft-versus-host disease.
This approval is based on results from an open-label, multi-center, single-arm Phase 1b/2 trial (PCYC-1129) evaluating the safety and efficacy of Imbruvica in 42 patients with cGVHD who required additional therapy after failure of first line corticosteroid therapy (median age of 56 years; range, 19 to 74 years old). The overall response rate (ORR) was 67% (95% CI: 51 per cent, 80%), with 21 per cent of patients achieving complete responses (CR; n=9) and 45% achieving partial responses (PR; n=19). The median steroid dose was reduced over time for the all-treated population, from 0.31 mg/kg/day at baseline to 0.14 mg/kg/day at week 48, and five patients were able to completely discontinue corticosteroids while in response.
