USA -Pfizer Inc.and Genmab  have announced that Tivdak® (tisotumab vedotin-tftv) has received full approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 

This milestone marks a significant advancement in addressing the urgent need for effective treatments in this patient population.

Recurrent or metastatic cervical cancer is a devastating and largely incurable disease, posing a significant challenge to patients and healthcare providers alike. 

Dr. Chris Boshoff, Chief Oncology Officer at Pfizer, emphasized the importance of this approval, stating, “Today’s full approval by the FDA reinforces the important role of TIVDAK for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”

The approval was based on robust data from the Phase 3 innovaTV 301 clinical trial (NCT04697628), which demonstrated a notable improvement in overall survival compared to chemotherapy. 

Dr. Boshoff noted, “The innovaTV 301 study demonstrated a 30% reduction in the risk of death compared to chemotherapy.

This significant survival benefit is a crucial advancement in the treatment landscape for recurrent or metastatic cervical cancer.

Dr. Jan van de Winkel, CEO of Genmab, echoed this sentiment, emphasizing the significance of Tivdak’s approval in extending survival for patients facing advanced stages of cervical cancer. 

He stated, “The full FDA approval of TIVDAK represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing TIVDAK as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments.”

Moreover, TIVDAK’s safety profile was consistent with previous findings, with no new safety concerns identified. 

Dr. Brian Slomovitz, Director of Gynecologic Oncology at Mount Sinai Medical Center, Miami Beach, emphasized the importance of the treatment’s safety profile, stating,As a treating physician, it is encouraging to see overall survival data among these patients and a manageable safety profile with tisotumab vedotin.”

TIVDAK’s journey to full approval began with its accelerated approval in September 2021, based on promising Phase 2 trial data. 

Following this, the drug underwent rigorous evaluation in the Phase 3 innovaTV 301 trial, which confirmed its efficacy and safety profile, leading to the recent full approval by the FDA.

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