ALPMY Astellas Pharma Inc (PK)

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)

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