DENMARK – The United States Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) from Pfizer Inc. and Genmab for Tivdak for the treatment of recurrent or metastatic cervical cancer.
Tivdak (tisotumab vedotin-tftv) is the only FDA-approved therapy in second-line recurrent or metastatic cervical cancer regardless of biomarker status, tumor histology and prior therapy.
According to a joint press release, the supplemental Biologics License Application has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 9, 2024.
The supplemental Biologics License Application is supported by efficacy and safety data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628).
In his address, Roger Dansey, M.D., Chief Development Officer of Oncology at Pfizer, said: “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.”
In October 2023, results from the innovaTV 301 study were presented during a Presidential Symposium at the European Society of Medical Oncology (ESMO) Congress.
The open-label study evaluated Tivdak vs investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received no more than 2 prior systemic regimens in the recurrent or metastatic setting.
TIVDAK demonstrated superior overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR), as assessed by the investigator, in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
“The Phase 3 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,” stated Roger Dansey.
Safety and efficacy were confirmed, in particular the safety profile of TIVDAK in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.
The U.S. Prescribing Information for Tivdak includes a boxed warning for Ocular Toxicity as well as the following warnings and precautions: peripheral neuropathy, hemorrhage, pneumonitis, severe cutaneous adverse reactions, and embryo-fetal toxicity.
Prior to the presentation of the results from the innovaTV 301 study, Tivdak was granted accelerated approval in the U.S. by the FDA in September 2021.
The accelerated approval is based on tumor response and durability of response from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating Tivdak as monotherapy in patients with previously treated recurrent or metastatic cervical cancer.
The data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial is expected to support global regulatory submissions.
For his part, Jan van de Winkel, Ph.D., Chief Executive Officer at Genmab, noted: “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.”
Concerningly, recurrent and/or metastatic cervical cancer is a particularly devastating and mostly incurable disease, with up to 16 percent of adults with cervical cancer are diagnosed with metastatic disease at diagnosis.
Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with a standard of care systemic chemotherapy doublet or platinum-based therapy (if eligible) are included.
For adults diagnosed at earlier stages who receive treatment, up to 61 percent will experience disease recurrence and progress to metastatic cervical cancer.
It is estimated that in 2023, more than 13,960 new cases of invasive cervical cancer will be diagnosed in the U.S. and 4,310 adults will die from the disease.
Consequently, Pfizer Inc. and Genmab are seeking to convert the accelerated approval of Tivdak to full approval, for the treatment of patients with recurrent or metastatic cervical cancer.
If approved, Tivdak will provide patients with a new treatment option for recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
“This milestone underscores our commitment to continuing to deliver TIVDAK as a treatment option to women in the U.S. diagnosed with cervical cancer whose disease has progressed after first-line treatment,” underscored Dr. Jan van de Winkel.