FDA Fully Approves TIVDAK® for Treating Recurrent or Metastatic Cervical Cancer

Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) have received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv), granting full approval for its use in treating patients with recurrent or metastatic cervical cancer whose disease has progressed following chemotherapy.

Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President at Pfizer, emphasized the significance of this approval, stating, “Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options. 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 FDA’s decision is based on findings from the global, randomized Phase 3 innovaTV 301 clinical trial (NCT04697628), where TIVDAK demonstrated an overall survival (OS) benefit compared to chemotherapy in adult patients with previously treated recurrent or metastatic cervical cancer. The study also met secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR). Results from the innovaTV 301 study were presented at the European Society of Medical Oncology (ESMO) Congress in October 2023.

According to the innovaTV 301 trial, patients treated with TIVDAK experienced a 30% reduction in the risk of death compared to chemotherapy. The median overall survival for TIVDAK-treated patients was 11.5 months compared to 9.5 months for those receiving chemotherapy.

Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab, expressed his satisfaction with the FDA’s decision, stating, “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.”

The U.S. Prescribing Information for TIVDAK includes important safety information, including a BOXED WARNING for Ocular Toxicity, as well as warnings and precautions regarding peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity.

As a treating physician, Brian Slomovitz, M.D., Director of Gynecologic Oncology at Mount Sinai Medical Center, Miami Beach, expressed optimism about the survival data observed with TIVDAK and its manageable safety profile. He emphasized the limited treatment options currently available for patients with advanced or recurrent cervical cancer and highlighted the need for more options demonstrating survival benefit.

The sBLA application for TIVDAK received a Priority Review Designation from the FDA, indicating its potential to offer significant advances in treatment or provide therapy in areas lacking adequate options. TIVDAK was initially granted accelerated approval in the U.S. in September 2021, based on tumor response and durability of response from the innovaTV 204 Phase 2 clinical trial. The full approval now converts the accelerated approval to full approval in the U.S.

Cervical cancer remains a disease with high unmet need despite advancements in vaccination and screening practices. Recurrent and metastatic cervical cancer presents significant challenges, with up to 15% of adults diagnosed with metastatic disease initially. The approval of TIVDAK offers a promising treatment option for this patient population.

For further information about TIVDAK and the innovaTV 301 clinical trial, visit www.clinicaltrials.gov.

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