FDA Grants Full Approval to Tivdak for Treating Recurrent or Metastatic Cervical Cancer Patients Experiencing Disease Progression After Chemotherapy

Image Credit: Adobe Stock Images/eddows

Pfizer and Genmab A/S announced that the FDA has granted a full approval to Tivdak (tisotumab vedotin-tftv) for patients with recurrent or metastatic cervical cancer who have experienced disease progression after chemotherapy. The drug previously received an accelerated approval in September 2021 for this indication.

The regulatory action was based on positive results from the Phase III innovaTV 301 clinical trial, which showed a significant improvement in survival rates, with a 30% reduction in the risk of death compared to chemotherapy. Additionally, secondary endpoints such as progression-free survival (PFS) and confirmed objective response rate (ORR) were also achieved.¹

“The full FDA approval of Tivdak represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing Tivdak as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments,” said Jan van de Winkel, PhD, CEO, Genmab, in a press release. “This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications.”

According to the Centers for Disease Control and Prevention (CDC), around 11,500 new cases of cervical cancer are reported in the United States each year, with an estimated 4,000 women dying from it. It is most common in women over the age of 30 and is mainly caused by infection with certain types of human papillomavirus (HPV). Current prevention methods of cervical cancer include screening and HPV vaccination. Additionally, the CDC suggests practicing safe sex and refraining from smoking.

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.³

“As a treating physician, it is encouraging to see overall survival data among these patients and a manageable safety profile with tisotumab vedotin,” said Brian Slomovitz, MD, director, gynecologic oncology, co-chair, Cancer Research Committee at Mount Sinai Medical Center, Miami Beach, in the press release. “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 US. 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 Biologics License Application (BLA) for Tivdak received a priority review designation back in January, as a sufficient treatment never existed previously.^4,5

"Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” said Chris Boshoff, MD, PhD, chief oncology officer, EVP, Pfizer, in the press release. “Today’s full approval by the FDA reinforces the important role of Tivdak for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”

References

1. FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer. Pfizer. April 29, 2024. Accessed April 30, 2024. https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-full-approval-tivdakr-treat-recurrent-or

2. Cervical Cancer. CDC. Accessed April 30, 2024. https://www.cdc.gov/cancer/cervical/stories/index.htm

3. 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 April 30, 2024.

4. FDA Grants Priority Review to Pfizer and Genmab's Tivdak for Cervical Cancer Treatment. PharmExec. January 9, 2024. Accessed April 30, 2024. https://www.pharmexec.com/view/fda-grants-priority-review-to-pfizer-and-genmab-s-tivdak-for-cervical-cancer-treatment

5. TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer. Pfizer. January 9, 2024. Accessed April 30, 2024. https://www.pfizer.com/news/press-release/press-release-detail/tivdakr-supplemental-biologics-license-application-accepted