`Versus-Host Disease
`lymphomanewstoday.com/2017/10/31/janssen-inc-announces-imbruvica-ibrutinib-as-the-first-approved-
`treatment-for-chronic-graft-versus-host-disease-cgvhd-granted-by-health-canada-priority-review/
`Janet Stewart, MSc
`
`October 31,
`2017
`
`Janssen‘s Imbruvica (ibrutinib) has been approved by Health Canada for treating chronic
`graft-versus-host disease (cGVHD), a life-threatening condition that some patients develop
`after a stem cell transplant.
`
`Following a priority review, Health Canada approved the drug as an oral, once-daily therapy
`for patients with steroid dependent or resistant cGVHD. The U.S. Food and Drug
`Administration approved Imbruvica for the same purpose in August.
`
`Imbruvica is a first-in-class Burton’s tyrosine kinase (BTK) inhibitor. Health Canada’s decision
`was based on results from the ongoing PCYC-1129 Phase 1b/2 trial (NCT02195869) showing
`that the drug is safe and efficacious in treating the condition.
`
`“Symptoms related to cGVHD can have a significant impact on a patient’s quality of life, and
`for most they come after an already long and difficult battle with a life-threatening disease
`such as leukemia or lymphoma,” Andrew Daly, MD, director of the Alberta Blood and
`Marrow Transplant Program said in a press release. Daly also is clinical associate professor
`at the Cumming School of Medicine, University of Calgary. “Physicians have had a real
`challenge finding options with compelling clinical data to treat cGVHD safely and effectively.
`This approval provides a much-needed new approach for patients who fail initial therapy, as
`data shows treatment with Imbruvica resulted in improved patient outcomes,” Daily said.
`
`1/2
`
`
`
`cGVHD is a life-threatening condition. It is a complication of stem cell transplants that
`happens when a donor’s immune cells attack the patient’s body, and occurs in 30 to 70
`percent of patients who receive stem cells from a partially matched donor (a sibling, for
`example). But current therapies involve corticosteroids, which damped the immune system
`and make patients more susceptible to infections or cancer progression.
`
`The Phase 1b/2 trial (NCT02195869) of Imbruvica included 42 patients with steroid
`dependent or refractory cGVHD, whose first line corticosteroid therapy had failed. Their
`ages ranged from 19 to 74 years.
`
`The most common malignancies that led to transplantation were acute lymphocytic
`leukemia (ALL), acute myeloid leukemia (AML), and chronic lymphocytic leukemia (CLL).
`
`Of the 42 patients, 21 percent achieved complete responses while 45 percent showed
`partial responses. Doses of steroids were reduced over the course of the study, with five
`patients completely discontinuing corticosteroids.
`
`“Lymphoma and leukemia patients are among those who may be able to get a stem cell
`transplant and achieve a potential cure. The procedure also comes with a high risk of
`cGVHD, which can have a severe impact on a patient’s ability to work and go about their
`day-to-day life,” said Robin Markowitz, CEO, Lymphoma Canada. “To date, many patients
`have had to rely on immunosuppressants and high-dose steroids to treat their cGVHD
`symptoms, and these come with significant issues. It is great news that patients finally have
`an approved treatment option.”
`
`Pharmacyclics, AbbVie, and Janssen Biotech are all involved in the development and
`commercialization of Imbruvica.
`
`2/2
`
`
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