Pfizer, Genmab Get Speedy FDA Review of Tivdak Full Approval

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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