Posted by Michael Wonder on 20 Sep 2021
Seagen and Genmab announce FDA accelerated approval for Tivdak (tisotumab vedotin-tftv) in previously treated recurrent or metastatic cervical cancer
20 September 2021 - Seagen and Genmab today announced that the U.S. FDA has granted accelerated approval to Tivdak (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Tivdak is approved under the FDA’s Accelerated Approval Program based on tumour response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
