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`l\JI life sciences·
`cancerNetwork®
`i·IM·li·W-----IENl-i+Eli::IHHEEllii-ifi:Hiiiiiiiil:iiii
`lbrutinib Approval Expanded to Include Chronic GVHD
`
`home of the journal ONCOLOGY
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`Enter your keywords
`
`By Leah Lawrence
`
`August 4, 2017
`
`Cancer ComP-lications, Hematologic Malignancies
`
`/brutinib is the first FDA-approved drug for treating GVHD.
`
`The US Food and Drug Administration (FDA) has approved the tyrosine kinase inhibitor ibrutinib (lmbruvica,
`Pharmacyclics) for adult patients with chronic graft vs host disease (GVHD) who have failed on one or more lines of prior
`systemic therapy. lbrutinib is the first drug to be approved by the FDA for the treatment of GVHD.
`
`"Unfortunately for patients who fail frontline corticosteroid therapy there are no approved or effective therapies," Lori Styles,
`MD, medical director of Pharmacyclics in Sunnyvale, California , told Cancer Network last year at the 58th Annual Meeting
`of the American Society of Hematology (ASH) , where results of a phase 1/11 study of ibrutinib in patients with chronic GVHD
`were presented. The FDA's approval was based on these results.
`
`VIDEO: Lori Styru, MD, on lbrutinib in Patients With Chronic GVHD
`
`The open-label , multicenter trial included 42 patients with chronic GVHD who had failed on corticosteroid therapy and
`required additional treatment. The majority of patients (88%) had at least two organs involved at baseline, most commonly
`the mouth (86%) , skin (81 %) , and gastrointestinal tract (33%).
`
`Patients were treated with oral ibrutinib 420 mg once daily. About two-third of patients (67%) responded to the drug. The
`median time to response coinciding with the first scheduled response assessment was 12.3 weeks and responses were
`seen in all organs involved. About one-half of patients (48%) had responses lasting 5 months or longer.
`
`'That is significant because [these patients] are also on corticosteroids, and those are effective but have a large associated
`morbidity and cause a lot of side effects ," Styles said. "Patients were able to sustain the response; they also showed a
`decrease in the use of corticosteroids."
`
`The most common adverse reactions were fatigue, bruising , diarrhea, thrombocytopenia , stomatitis , muscle spasms ,
`nausea, hemorrhage, anemia , and pneumonia. About one-quarter of patients had to discontinue treatment due to adverse
`reactions to the drug.
`
`Pharmacvciics Exhib it 2044
`Sandoz v. Pharmacyci ics
`IPR20 19-00865
`
`https://www.cancernetwork.com/cancer-complications/ibrutinib-approval-expanded-include-chronic-gvhd[12/2/2019 11 :13 :07 AM]
`
`

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`Commenting on this approval, James L. M. Ferrara, MD, DSc, the Ward-Coleman Chair in Cancer Medicine and Director of
`the Hematologic Malignancies Translational Research Center at the Tisch Cancer Institute at Mount Sinai in New York said,
`"This is an important advance and great news for our patients, because it is the first drug to be approved for this difficult
`condition. Chronic GVHD is a major complication of bone marrow and stem cell transplants that can be fatal when it does
`not respond to therapy, and a number of trials have failed in the past. The response rate here is very high and extremely
`encouraging. Further trials will test whether ibrutinib can be used as primary therapy at the onset of disease, perhaps
`providing even better responses."
`
`The FDA previously approved ibrutinib for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic
`lymphoma (SLL), CLL/SLL with 17p deletion, Waldenstrom macroglobulinemia, marginal zone lymphoma, and mantle cell
`lymphoma.
`
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