Pfizer, Genmab Get Speedy FDA Review of Tivdak Full Approval
January 09 2024 - 7:45AM
Dow Jones News
By Colin Kellaher
Pfizer and Genmab on Tuesday said the U.S. Food and Drug
Administration granted priority review to their request to convert
the accelerated approval of Tivdak for certain patients with
cervical cancer to full approval.
The companies said the FDA has set a target action date of May 9
for the application, which is based on positive results from a
global Phase 3 study that showed overall survival benefit of Tivdak
over chemotherapy in patients with recurrent or metastatic cervical
cancer with disease progression on or after first-line therapy.
The FDA granted accelerated approval to Tivdak in September
2021.
Copenhagen biotechnology company Genmab and Seagen, which New
York-based Pfizer acquired last year in a $43 billion deal, are
co-developing Tivdak by Genmab and Seagen, 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
January 09, 2024 07:30 ET (12:30 GMT)
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