`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`210563Orig1s000
`210563Orig2s000
`
`NON-CLINICAL REVIEW(S)
`
`
`
`
`
`
`
`
`MEMORANDUM
`
`Date:
`From:
`
`February 13, 2018
`Shwu-Luan Lee, PhD
`Nonclinical Reviewer
`Division of Hematology Oncology Toxicology (DHOT)
`for Division of Hematology Products (DHP)
`Through: Christopher M. Sheth, PhD
`Nonclinical Supervisor
`NDA 210563 ibrutinib
`Nonclinical Review
`
`To:
`Re:
`
`Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Mantle cell
`lymphoma (MCL), Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma
`(SLL), CLL/SLL with 17p deletion, Waldenström’s macroglobulinemia (WM), and
`Marginal zone lymphoma (MZL) who require systemic therapy and have received at
`least one prior anti-CD20-based therapy, and Chronic graft versus host disease
`(cGVHD) after failure of one or more lines of systemic therapy. NDA 210563 is a Type-3
`NDA for a tablet dosage form of the approved active ingredient ibrutinib. A capsule
`dosage form of ibrutinib (NDA 205552) is commercially available in the US under the
`trade name Imbruvica®. The nonclinical review is complete under NDA 205552. Refer
`to the documented review in DARRTS (NDA 205552 eCTD005) for additional details.
`There are no nonclinical issues that would prevent approval of this application.
`
`Reference ID: 4221173
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHWU LUAN LEE
`02/13/2018
`
`CHRISTOPHER M SHETH
`02/13/2018
`
`Reference ID: 4221173
`
`(
`
`
`
`
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