Accelerated FDA approval for Genmab and Seagen's Tivdak

The US Food and Drug Administration has granted accelerated approval to Tivdak IV (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Developed by Danish firm Genmab (OMX: GEN), whose shares edged up 2.3% to 2,803 Danish kroner on the news, and US biotech Seagen (Nasdaq: SGEN), Tivdak is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

The drug has been described as a “Trojan horse” because of its ability to sneak inside cancer cells. Binding to tissue factor draws the drug inside cancer cells, where it can kill them from within.