FDA converts Tivdak approval to full approval for cervical cancer
The agency granted traditional approval on April 29, 2024, moving tisotumab vedotin-tftv beyond its earlier accelerated clearance.
The FDA granted traditional approval to tisotumab vedotin-tftv on April 29, 2024, for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy. The drug is sold as Tivdak and was developed by Seagen Inc., which the FDA notes is now part of Pfizer Inc.1
This action follows the drug's earlier accelerated approval. The FDA had previously granted accelerated approval to tisotumab vedotin-tftv, marketed as Tivdak by Seagen Inc., for the same patient population of adults with recurrent or metastatic cervical cancer progressing on or after chemotherapy.2
Tisotumab vedotin-tftv previously received accelerated approval1 before this conversion to traditional approval status.
The documents reviewed do not specify the confirmatory trial data, response rates, or other clinical results that supported the conversion from accelerated to traditional approval. Readers seeking those specifics, along with dosing information and full prescribing details, should consult the FDA's complete approval record or the drug's prescribing information, as that level of detail is not included in the source materials reviewed for this report.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.