J&J's Janssen Seeks FDA OK for Expanded Imbruvica Use

Date : 11/08/2019 @ 1:27PM
Source : Dow Jones News
Stock : AbbVie Inc (ABBV)
Quote : 87.84  -0.89 (-1.00%) @ 12:59AM
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J&J's Janssen Seeks FDA OK for Expanded Imbruvica Use

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By Colin Kellaher

 

Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. unit on Friday said it filed a supplemental new-drug application with the U.S. Food and Drug Administration for the expanded use of the cancer drug Imbruvica.

Janssen said it is seeking approval of Imbruvica in combination with rituximab for the first-line treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The company said the filing is based on positive results from a phase 3 study of the combination that met the primary endpoints of progression-free survival and overall survival compared to the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab.

Imbruvica, which is jointly developed and commercialized by J&J's Janssen Biotech Inc. unit and AbbVie Inc.'s (ABBV) Pharmacyclics LLC, was first approved by the FDA in 2013 and is currently indicated in six disease areas.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

November 08, 2019 08:12 ET (13:12 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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