FDA Converts Tivdak’s Accelerated Approval to Full Approval for Cervical Cancer


A phase 3 trials showed Tivdak demonstrated a 30% reduction in the risk of death. The U.S. list price is $6,599 per 40 mg single dose vial.

The FDA has approved Pfizer’s supplemental biologics license application (sBLA) granting full approval for Tivdak (tisotumab vedotin-tftv) to treat patients with recurrent or metastatic cervical cancer. 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.

Brian Slomovitz, M.D.

Brian Slomovitz, M.D.

“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 United States,” Brian Slomovitz, M.D., director of Gynecologic Oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center, Miami Beach, said in a news release.

The FDA had granted Tivdak accelerated approval in September 2021 based on tumor response and durability of response from the innovaTV 204 pivotal phase 2 single-arm trial.

The full approval 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. Median overall survival for patients treated with Tivdak was 11.5 months compared with 9.5 months. for chemotherapy.

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.

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 acquired in December 2023 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.

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