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The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.
The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) intended to convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) in 2021 to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
TOKYO, Jan. 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. today announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License...
– Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy – ...
TIVDAK sBLA accepted for priority review, FDA action date is May 9, 2024 Submission based on positive results from global phase 3 innovaTV 301 trial demonstrating overall survival benefit of...