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FDA Grants Full Approval for Tivdak® to Treat Recurrent or Metastatic Cervical Cancer

Pfizer and Genmab announced that the US Food and Drug Administration (FDA) has granted full approval for Tivdak® (tisotumab vedotin-tftv) as the first antibody-drug conjugate (ADC) treatment for recurrent or metastatic cervical cancer. The approval underscores Tivdak's role as a vital treatment option for patients progressing after chemotherapy. It demonstrates positive overall survival data, showing a 30% reduction in the risk of death compared to chemotherapy in a Phase 3 trial.

Dr. Chris Boshoff, Chief Oncology Officer and Executive Vice President at Pfizer, emphasized the pivotal role of TIVDAK in providing tangible benefits to patients facing recurrent or metastatic cervical cancer. He noted “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.”

InnovaTV 301 clinical trial

Results from the global, randomized Phase 3 innovaTV 301 clinical trial (NCT04697628) formed the basis for the FDA's approval of TIVDAK for recurrent or metastatic cervical cancer. The trial successfully met its primary endpoint, demonstrating a 30% reduction in the risk of death compared to chemotherapy, with a median overall survival of 11.5 months for TIVDAK-treated patients versus 9.5 months for chemotherapy-treated patients.

Dr. Jan van de Winkel, CEO of Genmab, highlighted the approval of TIVDAK as a significant achievement for women battling recurrent and metastatic cervical cancer. “This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications,” he said.

The safety profile of TIVDAK

Common adverse reactions (>25%) included decreased hemoglobin (41%), peripheral neuropathy (38%), conjunctival reactions (37%), increased aspartate and alanine aminotransferase (34% and 30% respectively), nausea (33%), fatigue (28%), decreased sodium (27%), epistaxis (26%), and constipation (25%). However, no new safety concerns were identified, providing reassurance to healthcare providers and patients alike.

Dr. Brian Slomovitz, Director of Gynecologic Oncology at Mount Sinai Medical Center, expressed optimism regarding TIVDAK's overall survival data and its manageable safety profile. “Treatment options for patients with advanced or recurrent cervical cancer are limited. The five-year survival rate for patients who have metastatic disease at diagnosis is less than 20% in the U.S.ii There is a high unmet need for more treatment options that have demonstrated survival benefit in the contemporary treatment landscape. The approval of tisotumab vedotin brings us a step closer to fulfilling that need.”


TIVDAK is an innovative antibody-drug conjugate (ADC) comprising Genmab's monoclonal antibody targeting tissue factor (TF) and Pfizer's ADC technology. Clinical data suggest its efficacy in treating recurrent or metastatic cervical cancer by binding to TF-expressing cancer cells, delivering the cytotoxic agent MMAE, disrupting microtubule networks, and inducing cell death. Accelerated approval was granted in 2021 for patients progressing after chemotherapy. TIVDAK demonstrates potential in mediating antibody-dependent cellular phagocytosis and cytotoxicity, offering a promising treatment option in oncology.


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