NEW YORK CITY (dpa-AFX) - The U.S. Food and Drug Administration approved the
supplemental Biologics License
Application or sBLA granting full approval for TIVDAK (tisotumab vedotin-tftv)
for the treatment of patients with recurrent or metastatic cervical cancer with
disease progression on or after chemotherapy, Pfizer Inc. (PFE) and Genmab A/S
(GMAB) said in a statement.

The approval was based on results from the global, randomized, Phase 3 innovaTV
301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating
overall survival benefit in adult patients with previously treated recurrent or
metastatic cervical cancer treated with TIVDAK compared to chemotherapy.
Secondary endpoints of progression-free survival and confirmed objective
response rate were also met.

The U.S. Prescribing Information for TIVDAK includes a BOXED WARNING for Ocular
Toxicity as well as the following Warnings and Precautions: peripheral
neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and
embryo-fetal toxicity.

For More Such Health News, visit rttnews.com



Copyright(c) 2024 RTTNews.com. All Rights Reserved

Copyright RTT News/dpa-AFX