Genmab, Pfizer Say FDA Approves Treatment for Cervical Cancer

Genmab and Pfizer say the US FDA has approved the supplemental Biologics License Application for Tivdak for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

• FDA action converts the 2021 accelerated approval of Tivdak to a full approval
• Tivdak is the first antibody-drug conjugate with demonstrated overall survival data to be granted full FDA approval in this patient population

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Christian Wienberg in Copenhagen at cwienberg@bloomberg.net

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Kati Pohjanpalo ...