Janssen Gets CHMP Positive Opinion for Expanded Use of Imbruvica in Combination with Rituximab
July 24 2020 - 10:06AM
Dow Jones News
By Michael Dabaie
Johnson & Johnson's Janssen Pharmaceutical Cos. said the
European Medicines Agency's Committee for Medicinal Products for
Human Use issued a positive opinion recommending marketing
authorization for Imbruvica in combination with rituximab for
adults with previously untreated chronic lymphocytic leukemia.
The positive opinion is based on data from the Phase 3 E1912
study.
The CHMP positive opinion comes after the U.S. Food and Drug
Administration's approval of this expanded indication in April. The
application will now be reviewed by the European Commission.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
July 24, 2020 09:51 ET (13:51 GMT)
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