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The FDA has granted priority review to a supplemental biologics license application seeking to convert the accelerated approval of tisotumab vedotin to a full approval for the treatment of patients with recurrent or metastatic cervical cancer whose disease progresses on or following frontline therapy. ....
Genmab A/S (GMAB) and Seagen Inc. (SGEN) said that the Phase 3 innovaTV 301 global trial in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy who received TIVDAK (tisotumab vedotin-tftv), compared with chemotherapy alone, met its primary endpoint of overall survival. ....