Tisotumab Vedotin-tftv Approved by FDA in Advanced Cervical Cancer


The FDA has approved tisotumab vedotin-tftv for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

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Tisotumab vedotin-tftv has received an approval from the FDA for some patients with metastatic cervical cancer.

The Food and Drug Administration has approved tisotumab vedotin-tftv (Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, the agency announced.1 The approval follows an accelerated approval in 2021 for this indication.

"Teatment options for patients with advanced or recurrent cervical cancer are limited. The 5-year survival rate for patients who have metastatic disease at diagnosis is less than 20% in the US," Brian Slomovitz, MD, Director of Gynecology Oncology and Co-Chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, said in a press release.2 "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."

The approval was based on the findings of the innovaTV 301 (NCT04697628) trial of 502 patients with recurrent or metastatic cervical cancer who had received one or two prior systemic regimens, including chemotherapy with or without bevacizumab and/or an anti-PD-(L)-1 agent.1

Patients who had active ocular surface disease, any prior episode of cicatricial conjunctivitis or ocular Stevens-Johnson syndrome, Grade 2 or higher peripheral neuropathy, or clinically significant bleeding issues or risks were excluded from the trial, according to the FDA.

Patients were evenly randomized to treatment with tisotumab vedotin administered at 2 mg/kg intravenously every 3 weeks or an investigator’s choice of chemotherapy, until unacceptable toxicity or disease progression.

Median overall survival was 11.5 months (95% CI: 9.8, 14.9) among patients treated with tisotumab vedotin and 9.5 months (95% CI: 7.9, 10.7) for patients treated with chemotherapy (HR 0.70 [95% CI: 0.54, 0.89] p-value 0.0038). Median progression-free survival was 4.2 months (95% CI: 4.0, 4.4) in the tisotumab vedotin cohort and 2.9 months (95% CI: 2.6, 3.1) for the chemotherapy cohort (HR 0.67 [95% CI: 0.54, 0.82] p-value <0.0001). The confirmed objective response rate was 17.8% (95% CI: 13.3, 23.1) and 5.2% (95% CI: 2.8, 8.8) in the tisotumab vedotin and chemotherapy arms, respectively. (p-value <0.0001).

"As a treating physician, it is encouraging to see overall survival data among these patients and a manageable safety profile with tisotumab vedotin," Slomovitz said in the release.2

The most common adverse reactions occurring in at least 25% of patients were decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation.1

Of note, the prescribing information for tisotumab vedotin includes a boxed warning for ocular toxicity, in addition to other warnings and precautions for hemorrhage, peripheral neuropathy, severe cutaneous adverse reactions, pneumonitis, and embryo-fetal toxicity.2

According to the FDA, the recommended dose of tisotumab vedotin is 2 mg/kg, with a maximum of 200 mg for patients 100 kg or more, administered as an intravenous infusion over 30 minutes every 3 weeks until progression or unacceptable toxicity.1

"Today marks a great day for patients, especially adults battling advanced cervical cancer," Tamika Felder, cervical cancer patient advocate, and Founder and Chief Visionary Officer for Cervivor, said in the release.2 "This full approval opens up new treatment paths for this patient community who have long faced limited options."


  1. FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. Accessed April 29, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer
  2. TIVDAK® (tisotumab vedotin-tftv) Receives U.S. FDA Approval to Treat Recurrent or Metastatic Cervical Cancer. News release. Genmab A/S and Pfizer Inc. April 29, 2024. Accessed April 30, 2024. https://www.businesswire.com/news/home/20240422914519/en/TIVDAK%C2%AE-tisotumab-vedotin-tftv-Receives-U.S.-FDA-Approval-to-Treat-Recurrent-or-Metastatic-Cervical-Cancer
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