FDA Assigns Review Date for Full Approval of Tivdak for Cervical Cancer

The FDA has accepted the supplemental biologics license application (sBLA) to convert the accelerated approval of Tivdak (tisotumab vedotin-tftv) to full approval and granted the application priority review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.

The FDA granted Tivdak accelerated approval in September 2021 to treat patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The accelerated approval was based on tumor response and durability of response from the innovaTV 204 pivotal phase 2 single-arm trial.

Tivdak has a black box warning about the risks of vision loss and corneal ulceration, and the prescribing information indicates an eye exam is required before each dose. The phase 2 trial found that 60% of patients treated with Tivdak had ocular adverse reactions, including conjunctival adverse reactions, dry eye, corneal adverse reactions, and blepharitis (eyelid inflammation).

Tivdak is an antibody-drug conjugate composed of Genmab’s human monoclonal antibody that binds to tissue-factor-expressing cancer cells and Seagen’s ADC technology. Seagen was recently acquired by Pfizer for about $43 billion. The U.S. list price is $6,599 per 40 mg single dose vial, but individual costs will vary based on a person’s body weight and how long they receive therapy, a company spokesperson said.

The supplemental BLA is based on efficacy and safety data from the phase 3 innovaTV 301 trial in which Tivdak demonstrated overall survival, progression-free survival and confirmed objective response rate in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.

In the phase 3 trial, Tivdak demonstrated a 30% reduction in the risk of death compared with chemotherapy and a 3 3% reduction in the risk of disease worsening or death compared with chemotherapy. The disease control rate, defined as the percentage of patients who achieved complete response, partial response, or stable disease, was 75.9%.

Results from the innovaTV 301 study were presented at the European Society of Medical Oncology (ESMO) Congress in October 2023. The study was conducted by Seagen.

Cervical cancer remains a disease with high unmet need. It was estimated that, in 2023, more than 13,960 new cases of invasive cervical cancer were diagnosed in the United States.