MCW scientists conducted a pivotal trial leading to expedited FDA approval of REZUROCK in the latter half of 2021, a new treatment for patients with chronic graft-versus-host disease (cGVHD). The disease occurs after stem cell transplant when immune cells from the donor attack the recipient. It’s often debilitating – and there are few treatments available.
“It's been exceedingly difficult for providers to care for patients with cGVHD, and this is the second cGVHD treatment ever to receive FDA approval that provides patients with a new option in their treatment toolbox,” said Nirav Shah, MD, Associate Professor, Hematology and Medical Oncology.
The FDA granted approval for the treatment based on research from the aptly named ROCKstar trial. Results achieved a 75% overall response rate, with patients experiencing significant symptom relief. REZUROCK is available to adults and pediatric patients 12 years and older and works by rebalancing a patient’s immune system by blocking Rho-associated coiled-coil kinase 2 (ROCK2).
“Being a top cancer center, we were invited to participate in this pivotal trial that contributed to FDA approval for this ground-breaking drug,” says Shah. “It demonstrates our commitment to advancing patient outcomes through high-quality translational cancer research.”