FDA Accepts sBLA for Tisotumab Vedotin-tftv for the Treatment of Recurrent, Metastatic Cervical Cancer


The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.

The FDA has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of (tisotumab vedotin-tftv) to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The sBLA was granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

Tisotumab vedotin is an antibody-drug conjugate (ADC) composed of human monoclonal antibody directed to tissue factor (TF) and ADC that utilizes a protease-cleavable linker which covalently attaches the microtubule-disrupting agent monomethyl auristatin E to the antibody. Currently, tisotumab vedotin is indicated in the US for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin was previously granted accelerated approval by the FDA in September 2021. This approval was based on tumor response and durability of response from the innovaTV 204 phase 2 trial that evaluated tisotumab vedotin as a monotherapy in patients with previously treated recurrent or metastatic cervical cancer.

The sBLA comes after efficacy and safety data from the global, randomized, phase 3 trial, innovaTV 301 (NCT04697628). The trial enrolled 502 patients with recurrent or metastatic cervical cancer who were randomly assigned to receive either tisotumab vedotin or chemotherapy in the recurrent or metastatic setting. The trial’s primary endpoint was overall survival (OS), and the main secondary outcomes were progression-free survival (PFS), confirmed objective response rate (ORR), time to response, and duration of response, as well as safety and quality of life outcomes.

“Therapeutic options for metastatic cervical cancer that not only demonstrate a survival advantage but also include a novel approach to treating this condition are needed,” said Jan van de Winkel, PhD, chief executive officer, Genmab, in a press release. “This milestone underscores our commitment to continuing to deliver [tisotumab vedotin] as a treatment option to women in the US diagnosed with cervical cancer whose disease has progressed after first-line treatment.”

In the innovaTV 301 trial, tisotumab vedotin demonstrated better OS, PFS, and confirmed ORR than chemotherapy in patients with previously treated recurrent or metastatic cervical cancer. In addition, the safety profile of tisotumab vedotin was consistent with its safety profile in current United States prescribing information and prior research.

The most common adverse effects (AEs) reported by patients on tisotumab vedotin, including laboratory abnormalities, were reductions in hemoglobin (52%), fatigue (50%), reductions in lymphocytes (42%), nausea (41%), peripheral neuropathy (PN; 39%), alopecia (39%), epistaxis (39%), conjunctival AEs (37%), hemorrhage (32%), reductions in leukocytes (30%), increases in creatinine (29%), dry eye (29%), diarrhea (25%), and rash (25%). Serious AEs occurred in 43% of patients, the most common being ileus (6%), hemorrhage (5%), pneumonia (4%), PN sepsis, constipation, and pyrexia (each 3%). Approximately 13% of patients how to discontinue treatment due to AEs, the most common being PN (5%) and corneal AEs (4%). Fatal AEs occurred in approximately 4% of patients who received treatment with tisotumab vedotin.

“The Phase 3 innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in OS, and adds to the overall data supporting [tisotumab vedotin] as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” said Roger Dansey, MD, chief development officer, oncology, Pfizer, in the press release. “The FDA acceptance of our sBLA for review is important progress toward continuing to offer an option that can extend the lives of more adults with cervical cancer.”


Pfizer. TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer. News release. January 9, 2024. Accessed January 10, 2024. https://www.pfizer.com/news/press-release/press-release-detail/tivdakr-supplemental-biologics-license-application-accepted

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