FDA Priority Review Granted to Tivdak for Cervical Cancer Based on Phase III innovaTV 301 Trial Data

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The FDA has accepted a supplemental Biologics License Application (sBLA) from Pfizer Inc. and Genmab A/S that would convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) to a full approval for patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy. The accelerated approval was granted by the FDA in September 2021, with the current sBLA given Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.¹

“The Phase III innovaTV 301 trial demonstrated a favorable benefit/risk profile, including improvement in overall survival, and adds to the overall data supporting Tivdak as a treatment option for people with recurrent and metastatic cervical cancer who have limited treatment options,” Roger Dansey, MD, chief development officer, Oncology at Pfizer, said in a 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.”¹

The regulatory submission is based on data for efficacy and safety from the global, randomized, Phase III innovaTV 301 trial (NCT04697628). The results showed that Tivdak produced superior overall survival, progression-free survival, and confirmed objective response rate vs. chemotherapy in patients previously treated for recurrent or metastatic cervical cancer. The drug’s safety profile in the trial was consistent with the known safety profile previously listed in the US prescribing information.

Tivdak is an antibody drug conjugate (ADC) that targets tissue factor (TF) on tumor cells. The drug comprises a TF-directed antibody attached to a cytotoxic microtubule inhibitor, monomethyl auristatin E (MMAE). ADCs are targeted therapies that have demonstrated promising results treating certain cancer types, such as acute leukemia, breast cancer, and Hodgkin lymphoma. An ADC is comprised of a cytotoxic drug artificially combined with a monoclonal antibody that has been developed to transport, selectively target, and bind to tumor antigens. The treatment delivers its cytotoxic payload to the tumor sites, subsequently resulting in cell death.²

Cervical cancer, which is a rare type of the disease originating from the cellular lining of the cervix, represents approximately 0.8% of all new cancer cases and 0.7% of all cancer deaths annually in the United States.³ There were an estimated 13,960 new cases of cervical cancer diagnosed with approximately 4,310 deaths from the disease in the United States in 2023, per data from the National Cancer Institute.³

Cervical cancer has a five-year relative survival rate of 66.3% and a 17.6% five-year survival rate in patients with distant metastatic disease.¹ Further, up to 15% of adults diagnosed with cervical cancer have metastatic disease, and among those adults diagnosed at earlier stages who were administered treatment, up to 31.5% experience disease recurrence.¹

“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,” Jan van de Winkel, PhD, chief executive officer at Genmab, said in a press release. “This milestone underscores our commitment to continuing to deliver Tivdak as a treatment option to women in the US diagnosed with cervical cancer whose disease has progressed after first-line treatment.”¹

References

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

2. Chau CH, Steeg PS, Figg WD. Antibody-drug conjugates for cancer. Lancet. 2019;394(10200)793-804. doi:10.1016/S0140-6736(19)31774-X. Accessed January 9, 2024.

3. Cancer stat facts: cervical cancer. National Cancer Institute. Accessed December 3, 2021. https://seer.cancer.gov/statfacts/html/cervix.html. Accessed January 9, 2024.