Incyte (INCY) Announces Acceptance and Priority Review of sNDA for Jakafi as Treatment for Patients with Chronic Graft-Versus-Host Disease

February 22, 2021 8:06 AM EST

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Incyte (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

The sNDA submission is based on results from the Phase 3, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT at Week 24, the primary endpoint (49.7% vs. 25.6%; p<0.0001). For the key secondary endpoints, ruxolitinib was associated with a longer median failure-free survival (FFS) than BAT at Week 24 (not reached vs. 5.7 months; hazard ratio (HR), 0.370; p<0.0001), and greater symptom improvement per the modified Lee Symptom Scale (mLSS) at Week 24 (24.2% vs. 11.0%; odds ratio (OR), 2.62; p=0.0011). The best ORR for patients receiving ruxolitinib was 76.4%. No new safety signals were observed, and adverse events were consistent with the known safety profile of ruxolitinib.

“Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “The acceptance of this sNDA represents an important milestone for Incyte as we continue our work towards helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States.”

GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs after 100 days of transplant1. Both forms can affect multiple organ systems, including the skin, gastrointestinal (digestive) tract and liver.

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to six months compared to 10 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for Jakafi in steroid-refractory chronic GVHD is June 22, 2021.

The sNDA is also being reviewed as part of the Project Orbis program, an initiative of the U.S. FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international regulatory agencies. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

In 2019, Jakafi was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older2.

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