Pfizer, Genmab get full FDA approval for cervical-cancer drug

By Ben Glickman

Pfizer and Genmab on Monday said they had received full approval from U.S. regulators for their treatment for certain forms of cervical cancer.

The companies' drug Tivdak had previously been granted accelerated approval by the U.S. Food and Drug Administration, which allows quicker approval for drugs addressing a serious unmet need. The FDA's full approval covers Tivdak in the treatment of recurrent or metastatic cervical cancer.

Danish biotechnology company Genmab and Pfizer-owned Seagen codeveloped Tivdak under a cost- and profit-sharing agreement.

Tivdak has had accelerated approval from the FDA for cervical-cancer treatment since 2021.

Genmab (GMAB) and Pfizer (PFE) said Monday that the antibody-drug conjugate had been approved to treat patients who have disease progression on or after chemotherapy, meaning it is a second-line treatment.

The approval was based on results from a Phase 3 trial of Tivdak, which met its primary endpoint of overall survival as well as its secondary endpoints, the companies said.

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04-29-24 1858ET

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