HQ Team
April 30, 2024: The US health regulator has approved Pfizer’s drug to treat cervical cancer patients whose disease has progressed beyond the chemotherapy stage.
The drug, an antibody-drug conjugate branded Tivdak, was co-developed by Danish company, Genmab A/S.
The US Food and Drug Administration gave the nod following results from late-stage trials conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab and other gynecological groups, according to a Pfizer statement.
The drug was added to Pfizer’s portfolio after the acquisition. It was originally granted accelerated approval in the US by the FDA in September 2021, based on tumor response and durability of response from stage-two trials.
30% less deaths
The late-stage trial demonstrated a 30% reduction in the risk of death in patients compared to chemotherapy, according to the statement.
“The primary endpoint, demonstrating overall survival benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with Tivdak compared to chemotherapy,” was met and secondary endpoints of “progression-free survival and confirmed objective response rate were also met.”
“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, Chief Executive Officer of Genmab.
“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.”
Devastating disease
Cervical cancer remains a disease with high unmet needs despite advances in effective vaccination and screening practices to prevent and diagnose pre-early-stage cancers for curative treatment.
Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease — up to 15% of adults with cervical cancer present with metastatic disease at diagnosis.
For adults diagnosed at earlier stages who receive treatment, up to 61%vi will experience disease recurrence. It was estimated that, in 2023, more than 13,960 new cases of invasive cervical cancer were diagnosed in the US and 4,310 adults would die from the disease.
“Treatment options for patients with advanced or recurrent cervical cancer are limited,” said Brian Slomovitz, M.D., Director of Gynecologic Oncology and Co-Chair of the Cancer Research Committee at Mount Sinai Medical Center, Miami Beach.
“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 benefits in the contemporary treatment landscape.
“The approval of tisotumab vedotin brings us a step closer to fulfilling that need.”
