On September 20, 2021, the FDA accelerated the approval of Tivdak (tisotumab vedotin-tftv; from Seagen and Genmab), a tissue factor–directed antibody and microtubule inhibitor conjugate administered as an intravenous infusion, for the treatment of women with recurrent (coming back) or metastatic (spreading) cervical cancer that progressed during or after receiving chemotherapy.
This is the first drug of this type that is approved for women with advanced cervical cancer, offering patients a much-needed new treatment option.
“Tivdak’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option,” said Jan van de Winkel, PhD, Chief Executive Officer of Genmab.
The FDA approved Tivdak based on results from an open-label, multicenter, single-arm clinical trial that included 101 patients with recurrent or metastatic cervical cancer who had received up to 2 regimens of systemic therapies that included at least 1 platinum-based chemotherapy regimen for recurrent or metastatic cervical cancer.
All the patients in this study received intravenous infusion of Tivdak every 3 weeks until their cancer progressed or they had unacceptable side effects.
The response rate to Tivdak therapy was 24%, meaning that almost a quarter of the patients had a response to this new treatment, and the average length of response was 8.3 months.
The most common side effects with Tivdak included reductions in some blood chemistry levels, fatigue, nausea, peripheral neuropathy, hair loss, bleeding (including nose bleeding), dry eye, diarrhea, and rash.
The prescribing information for Tivdak includes a warning to doctors about the potential for serious ocular side effects.