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FDA Grants Complete Approval for Tivdak in Treating Recurrent or Metastatic Cervical Cancer

Marking a significant milestone in cancer treatment, Tivdak has received full approval from the FDA as the first antibody-drug conjugate (ADC) to show positive overall survival outcomes for patients previously treated for recurrent or metastatic cervical cancer.

This transition to full approval follows encouraging results from a global Phase 3 trial, demonstrating Tivdak's superiority over chemotherapy in terms of overall survival.


The FDA has greenlit the supplemental Biologics License Application (sBLA) for Tivdak (tisotumab vedotin) for managing patients with recurrent or metastatic cervical cancer experiencing disease progression post-chemotherapy. This decision stems from findings of the worldwide, randomized Phase 3 study known as innovaTV 301 clinical trial (NCT04697628), where Tivdak showcased a notable improvement in overall survival (OS) for adult patients compared to chemotherapy after prior treatment for recurrent or metastatic cervical cancer.

Secondary endpoints such as progression-free survival (PFS) and confirmed objective response rate (ORR) were also met.

Results from the innovaTV 301 trial demonstrated a 30% reduction in the risk of death with Tivdak compared to chemotherapy, with patients treated with Tivdak experiencing a median OS of 11.5 months versus 9.5 months with chemotherapy.


The safety profile of Tivdak in the innovaTV 301 trial aligned with its known safety profile as outlined in the U.S. prescribing information, with no identification of new safety concerns. The most frequently reported adverse reactions, including laboratory abnormalities, among patients receiving Tivdak were decreased hemoglobin (41%), peripheral neuropathy (38%), conjunctival adverse reactions (37%), increased aspartate aminotransferase (34%), nausea (33%), increased alanine aminotransferase (30%), fatigue (28%), decreased sodium (27%), epistaxis (26%), and constipation (25%).


The sBLA application was granted Priority Review Designation, a distinction awarded by the FDA to drugs offering significant advancements in treatment or filling an unmet therapeutic need.


Tivdak initially received accelerated approval in the U.S. by the FDA in September 2021, based on tumor response and response durability data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial, which assessed Tivdak in patients with previously treated recurrent or metastatic cervical cancer. With the FDA's approval of the sBLA, Tivdak's accelerated approval has been converted to full approval in the U.S.


The innovaTV 301 trial (NCT04697628) was a global, 1:1 randomized, open-label Phase 3 study comparing Tivdak (tisotumab vedotin) to investigator-selected single-agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who had previously received chemotherapy in the recurrent or metastatic setting.


Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) were eligible for inclusion. The primary endpoint was overall survival, while progression-free survival and objective response rate served as key secondary outcomes.


The trial was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, the European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12), the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), and other global gynecological oncology cooperative groups.


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