J&J's Janssen Seeks FDA OK for Expanded Imbruvica Use
November 08 2019 - 7:27AM
Dow Jones News
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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