Dr. Coleman on the FDA Approval of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Robert L. Coleman, MD, FACOG, FACS, chief scientific officer of The US Oncology Network, discusses the FDA approval of tisotumab vedotin-tftv (Tivdak) in recurrent or metastatic cervical cancer.

On September 20, 2021, the FDA granted an accelerated approval to tisotumab vedotin for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The approval was based on findings from the phase 2 innovaTV 204 trial (NCT03438396), in which the antibody-drug conjugate induced a 24% objective response rate in patients with recurrent or metastatic cervical cancer who previously received doublet chemotherapy and bevacizumab (Avastin). 

Tisotumab vedotin provides another treatment option to patients with recurrent or metastatic cervical cancer, says Coleman. Historically, very few treatment options have demonstrated efficacy in this patient population, including immunotherapy, Coleman explains. Although a proportion of patients respond well to immunotherapy, the majority of patients with cervical cancer will not benefit from this treatment approach, Coleman adds.

As such, tisotumab vedotin offers an option for patients with cervical cancer who need an effective therapy that acts rapidly, concludes Coleman.