Janssen Gets Positive CHMP Opinion on Expanded Use of Imbruvica
June 28 2019 - 8:49AM
Dow Jones News
By Michael Dabaie
Johnson & Johnson's (JNJ) Janssen Pharmaceutical Cos. said
the Committee for Medicinal Products for Human Use of the European
Medicines Agency recommended broadening the existing marketing
authorization for Imbruvica, or ibrutinib, in two indications.
One recommendation is for the use of ibrutinib in combination
with obinutuzumab in adult patients with previously untreated
chronic lymphocytic leukemia. The second is for use of ibrutinib
plus rituximab for the treatment of adult patients with
Waldenstrom's macroglobulinemia.
Both positive opinions will now be reviewed by the European
Commission, which has the authority to grant final approval of the
indications.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
June 28, 2019 08:34 ET (12:34 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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