The Food and Drug Administration (FDA) has approved Prograf (tacrolimus) for use in combination with immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving allogeneic lung transplantation. Previously, the treatment was only approved to prevent organ rejection in patients receiving kidney, liver, or heart transplants.
The approval was based on an observational study using real-world data from the US Scientific Registry of Transplant Recipients. The study analyzed outcomes based on discharge immunosuppression treatment regimen in recipients of a primary lung transplant between 1999 and 2017 who were alive at the time of discharge.
Findings showed that among adults who received tacrolimus immediate-release products in combination with mycophenolate mofetil (MMF; n=15,478) or azathioprine (AZA; n=4263), the 1-year graft survival estimates from time of discharge were 90.9% and 90.8%, respectively. Among pediatric patients receiving tacrolimus immediate-release products in combination with MMF (n=450) or AZA (n=72), the 1-year graft survival estimates from time of discharge were 91.7% and 84.7%, respectively.
The approval was also supported by data from randomized controlled trials of tacrolimus in other solid organ transplant settings, as well as clinical trial evidence from research publications evaluating tacrolimus as part of a multidrug immunosuppressive regimen.
- FDA approves new use of transplant drug based on real-world evidence. News release. US Food and Drug Administration. Accessed July 16, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-use-transplant-drug-based-real-world-evidence.
- Prograf [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2021.