Pfizer Inc. (PFE) and Genmab A/S (GMAB) Tuesday said the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application for TIVDAK for Priority Review for the treatment of patients with recurrent or metastatic cervical cancer.
A decision from the regulator is expected on May 9, 2024.
TIVDAK, co-owned by Genmab and Pfizer, was granted accelerated approval by the FDA in September 2021.
The supplemental Biologics License Application was supported by data from the Phase 3 innovaTV 301 trial in which TIVDAK showed superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
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