FDA Grants Approval to Medication to Treat Recurrent or Metastatic Cervical Cancer

The FDA has granted full approval for a treatment called TIVDAK for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

TIVDAK is the first “antibody-drug conjugate with statistically significant prolonged overall survival data” approved by the FDA. A Phase 3 innovaTV 301 clinical trial was undertaken to prove its efficacy. The trial demonstrated “overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy.”

The study ultimately demonstrated a “30% reduction in the risk of death compared to chemotherapy,” and median OS for patients treated with TIVDAK was 11.5 months compared to those treated with chemotherapy, at 9.5 months.

In addition, the safety profile of TIVDAK “was consistent with its known safety profile as presented in the U.S. prescribing information.”

The five-year survival rate for patients who have metastatic disease at diagnosis is “less than 20% in the U.S.,” according to Brian Slomovitz, M.D., leading to a “high unmet need for more treatment options that have demonstrated survival benefit in the contemporary treatment landscape.”

Metastatic cervical cancer is particularly devastating because “up to 15% of adults with cervical cancer present with metastatic disease at diagnosis,” and “up to 61%” of adults diagnosed at earlier stages “will experience disease recurrence.”