FDA Accepts sBLA For Tivdak In Recurrent or Metastatic Cervical Cancer

The FDA will review Tivdak for the treatment of recurrent or metastatic cervical cancer.

The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) intended to convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) in 2021 to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy, according to a news release from manufacturers Pfizer Inc. and Genmab A/S.

The application, according to the news release, received Priority Review with a Prescription Drug User Fee Act (PDUFA) date of May 9, 2024.

Tivdak was the first antibody drug conjugate (a type of targeted cancer treatment) approved for this patient population, and according to the release from Pfizer and Genmab its continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Results from the phase 3 innovaTV 301/ENGOT-cx12/GOG-3057 trial presented at the 2023 ESMO Congress showed that Tivdak reduced the risk of death by 30% versus chemotherapy as a second- or third-line treatment for this patient population. Trial results, which supported the sBLA, also showed improved overall survival (OS; the time a patient lives regardless of disease status), progression-free-survival (PFS; how long a patient lives without their disease spreading or worsening) and confirmed objective response rate (patients whose disease responded partially or completely to treatment).

Read More: Tivdak Improves Survival Rates in Advanced Cervical Cancer

According to findings from the innovaTV 301 trial, any-grade treatment-related side effects occurred in 87.6% of patients treated with Tivdak and 85.4% of patients who were treated with chemotherapy arm, while two patients in the Tivdak arm and one patient in the chemotherapy arm died due to treatment-related side effects.

The most common treatment-related side effects among patients treated with Tivdak and chemotherapy, respectively, were anemia (12.8% and 43.9%), nausea (29.2% and 36%), conjunctivitis (pink eye; 30.4% and 0%), peripheral sensory neuropathy (nerve damage; 26.8% and 2.1%), alopecia (hair loss; 24.4% and 2.9%), epistaxis (nosebleeds; 22.8% and 2.1%), neutropenia (low counts of neutrophils, a type of white blood cell, 6.4% and 21.8%), decreased appetite (18% and 10%), diarrhea (16% and 8.8%) and keratitis (inflammation of the cornea; 15.6% and 0%).

“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,” said Dr. Roger Dansey, chief development officer, oncology, at Pfizer in the news 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.”

The American Cancer Society estimated that there would be approximately 13,960 new cases of invasive cervical cancer and approximately 4,310 deaths from cervical cancer in the United States in 2023.

“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,” said Jan van de Winkel, chief executive officer at Genmab in the news release. “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.”

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