Astellas Pharma, Seagen Get CHMP Positive Opinion for Padcev
17 December 2021 - 11:37PM
Dow Jones News
By Chris Wack
Astellas Pharma Inc. and Seagen Inc. said the Committee for
Medicinal Products for Human Use of the European Medicines Agency
has adopted a positive opinion for Padcev.
The companies said CHMP has recommended approval of the
antibody-drug conjugate Padcev enfortumab vedotin as monotherapy
for the treatment of adult patients with locally advanced or
metastatic urothelial cancer who have previously received
platinum-containing chemotherapy and a PD-1/L1 inhibitor.
If approved by the European Commission, enfortumab vedotin will
be the first ADC authorized in the European Union for people living
with advanced urothelial cancer.
The CHMP recommendation is based on data from a phase 3 trial,
which evaluated enfortumab vedotin versus chemotherapy in adult
patients with locally advanced or metastatic urothelial cancer who
were previously treated with platinum-based chemotherapy and a
PD-1/L1 inhibitor. Results from the trial, which had a primary
endpoint of overall survival, were published in the New England
Journal of Medicine.
The positive opinion from the CHMP will now be reviewed by the
EC.
EC decisions are valid in the European Union Member States, as
well as Iceland, Norway and Liechtenstein.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
December 17, 2021 07:22 ET (12:22 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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