FDA Approves Jakafi to Treat Chronic GVHD

The overall response rate of ruxolitinib at week 24 was 49.7% compared with 25.6% for the best available therapy treatment for graft-versus-host-disease.

The FDA has approved ruxolitinib (Jakafi, Incyte) to treat chronic graft-versus-host disease (GVHD) after the failure of 1 or 2 lines of systemic therapy in individuals aged 12 years and older.

“GVHD is the leading cause of morbidity and mortality in patients following an allogeneic stem cell transplant, yet there historically have been limited treatment options available beyond first-line systemic therapies,” Steven Stein, MD, chief medical officer at Incyte, said in a statement.

Results of the REACH3 study showed that ruxolitinib had a better overall response rate (ORR) compared with the best available therapy for treatment of GVHD after allogeneic stem cell transplantation.

The ORR at week 24 was 49.7% for ruxolitinib compared with 25.6% for the alternative drug. The ORR through cycle 7, day 1, was 70% for ruxolitinib compared with 57% for the alternative drug.

“Incyte is proud to have contributed to the overall scientific understanding of GVHD through our REACH program, which has led to important treatment advances on behalf of patients and the medical community, including today’s approval of Jakafi for certain people who develop chronic GVHD,” Stein said.

The most common adverse reactions were anemia, thrombocytopenia, and viral infections.

The REACH3 study results were published in the New England Journal of Medicine.

GVHD can occur after an allogeneic stem cell transplant in which the donated cells initiate an immune response and attack the transplant recipient’s organs.

“In the US, there are over 14,000 people living with chronic GVHD, many of whom face significant complications that may impair daily activities and linger for years,” Susan Stewart, executive director at BMT InfoNet, said in the statement. “The approval of Jakafi is an exciting development for the GVHD community and an important step forward in the treatment of a disease with few options.”

Reference

Incyte announces FDA approval of Jakafi (ruxolitinib) for treatment of chronic graft-versus-host disease (GVHD). Business Wire. News release. September 22, 2021. Accessed September 23, 2021. https://www.businesswire.com/news/home/20210922005863/en