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Seagen, Genmab See Broad Cervical Cancer Opportunity For Tisotumab Vedotin

US FDA Clears Monotherapy Use

 
• By Joseph Haas

At ESMO, data showed objective response benefit in combination with carboplatin in first-line therapy, and with Keytruda in second- or third-line treatment. The antibody-drug conjugate obtained US approval on 20 September as monotherapy.

Research scientist
Seagen's ADC Tivdak, partnered with Genmab, obtains US approval, positions for other indications

Seagen Inc. and Genmab A/S seem to be well positioned for wide use of their antibody-drug conjugate tisotumab vedotin in cervical cancer, with US Food and Drug Administration approval for monotherapy and interim data from regimens tested in a Phase Ib/II study supporting combination use in first-, second- and third-line treatment of recurrent or metastatic disease.

The FDA issued accelerated approval for the ADC – under the brand name Tivdak – on 20 September, ahead of its 10 October user fee date, for use as monotherapy in recurrent or metastatic cervical cancer that progresses on or after chemotherapy. Tivdak is Seagen’s fourth approved cancer therapy, following the ADC Adcetris (brentuximab vedotin) for multiple types of lymphoma; a second ADC, Padcev (enfortumab vedotin) for urothelial cancer; and Tukysa (tucatinib), a tyrosine kinase inhibitor for HER2-positive breast cancer

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