The U.S. Food and Drug Administration (FDA) has granted full approval to TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer who have undergone prior chemotherapy.
The approval is based on results from the Phase 3 innovaTV 301 trial, which demonstrated significant overall survival (OS) benefits for patients treated with TIVDAK compared to chemotherapy. The median OS was 11.5 months for patients receiving TIVDAK versus 9.5 months for those receiving chemotherapy.
The trial also met secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR).
The safety profile of TIVDAK is consistent with its known adverse events, including peripheral neuropathy, hemorrhage, pneumonitis, and ocular toxicity. The most common side effects observed in the innovaTV 301 trial were hemoglobin decrease, peripheral neuropathy, and conjunctival adverse reactions.
TIVDAK is the first antibody-drug conjugate to demonstrate statistically significant OS prolongation in patients with recurrent or metastatic cervical cancer. This approval provides a new treatment option for patients with this devastating disease.
Genmab is continuing its clinical development program to explore the potential of TIVDAK in other indications.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
