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)

Copyright (c) 2020 Dow Jones & Company, Inc.
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