FDA label expansions: Full approval for Tivdak in April

In April, FDA approved at least six supplemental applications for use in younger populations, four for new indications and a full approval for Tivdak. 

Tivdak tisotumab vedotin, a tissue factor antibody drug conjugate (ADC) with microtubule inhibitor, was granted full approval for recurrent or metastatic cervical cancer. In the Phase III innovaTV 301 trial, Tivdak showed a 30% reduction in risk of death compared with chemotherapy (HR=0.70, two-sided p=0.0038). Median overall survival was 11.5 months, compared with 9.5 months with chemotherapy. Pfizer Inc. (NYSE:PFE) gained Tivdak through its acquisition of Seagen Inc. last year. ...