Genmab, Pfizer Get European Review of Cervical Cancer Drug
By Colin Kellaher
The European Medicines Agency has validated for review an application from Genmab and Pfizer seeking approval of their tisotumab vedotin antibody-drug conjugate for certain adults with cervical cancer.
Genmab and Pfizer on Friday said the application covers adults with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
The companies said a green light would make tisotumab vedotin the first antibody-drug conjugate approved in the European Union for people with cervical cancer.
The U.S. Food and Drug Administration in 2021 granted accelerated approval to tisotumab vedotin, marketed as Tivdak, and last month granted priority review to a request by Genmab and Pfizer to convert the accelerated nod to full approval.
Copenhagen biotechnology company Genmab and New York-based Pfizer are co-developing Tivdak under an agreement in which the companies share costs and profits for the product on a 50-50 basis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 02, 2024 07:29 ET (12:29 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
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