Genmab and Seagen's BLA for tisotumab vedotin accepted for priority review

The US Food and Drug Administration has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin, that was submitted to the agency by Danish biotech firm Genmab (OMX: GEN) and US firm Seagen (Nasdaq: SGEN) in February this year.

This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021.

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