Thursday , August 24 2017
Home / FDA News / Incyte Announces First Patient Treated in Pivotal Clinical Trial Program for Jakafi for GVHD

Incyte Announces First Patient Treated in Pivotal Clinical Trial Program for Jakafi for GVHD

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in the REACH-1 pivotal Phase 2 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD).

“We are very pleased to have the first patient treated in the pivotal trial program for ruxolitinib in GVHD, a severe and often life-threatening condition for which there are currently no approved treatments,” said Steven Stein, M.D. Incyte’s Chief Medical Officer. “We look forward to building on the clinical evidence to-date for ruxolitinib and working with regulators to help address the urgent needs of these patients.”

GVHD is a condition that might occur after an allogeneic transplant (the transfer of genetically dissimilar blood stem cells). In GVHD, the donated bone marrow or peripheral blood stem cells view the recipient’s body as foreign and attack the body. There are two forms of GVHD: acute and chronic. GVHD is a significant cause of morbidity and mortality in transplant recipients. The skin, gastrointestinal (digestive) tract, and liver are the most commonly affected organs in patients with acute GVHD.

The U.S. Food and Drug Administration (FDA) has granted ruxolitinib Breakthrough Therapy Designation for the treatment of acute GVHD, designed to expedite the development and review of drugs for serious or life-threatening conditions, as well as Orphan Drug Designation for the treatment of GVHD, granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

About REACH

The REACH clinical trial program for ruxolitinib in steroid-refractory acute GVHD includes the Incyte-sponsored REACH-1 study—a single-cohort, pivotal Phase 2 study (NCT02953678) evaluating ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD—and is also expected to include collaborative Novartis-sponsored randomized pivotal studies in steroid-refractory acute GVHD and steroid-refractory chronic GVHD. The Novartis-sponsored pivotal studies are expected to begin in early 2017.

The primary endpoint of the REACH-1 study is overall response rate at day 28. Key secondary endpoints include duration of response, overall response rate at day 14, 56, and 100, non-relapse mortality and safety. For more information about the study, please visit https://clinicaltrials.gov/show/NCT02953678.

About Jakafi®(ruxolitinib)

Ruxolitinib is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration, as Jakafi® (ruxolitinib), for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.

Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

Increases in Cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: low platelet count, low red blood cell counts, bruising, dizziness, headache.

These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider. Do not drink grapefruit juice while on Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or if breast-feeding.

Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte

Check Also

Epygenix’s EPX-300 Receives Orphan Drug Designation from the FDA for Treatment of Dravet Syndrome

PARAMUS, N.J., Aug. 23, 2017 /PRNewswire/ — Epygenix Therapeutics, Inc., a privately held biopharmaceutical company …