J&J Unit Gets CHMP Positive Opinion for Apalutamide
November 16 2018 - 9:19AM
Dow Jones News
By Colin Kellaher
Johnson & Johnson (JNJ)'s Janssen Pharmaceutical Cos. unit
on Friday said the European Medicines Agency's Committee for
Medicinal Products for Human Use issued a positive opinion for
apalutamide to treat a form of prostate cancer.
Janssen said the opinion, which covers the treatment of adults
with non-metastatic castration-resistant prostate cancer who are at
high risk of developing metastatic disease, will be reviewed by the
European Commission, which has the authority to grant approval.
The U.S. Food and Drug Administration approved apalutamide for
the indication in February.
Janssen said the positive opinion is based on data from a phase
3 study that showed apalutamide significantly improved
metastasis-free survival for patients with castration-resistant
prostate cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 16, 2018 09:04 ET (14:04 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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