The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the drug called Tivdak for patients with recurrent or metastatic cervical cancer, according to BioSpace.
The agency has approved the drug for metastatic cervical cancer that has progressed on or after chemotherapy.
Tivdak (tisotumab vedotin-tftv), developed by the biotechnology company Seagen, is the first and only approved antibody-drug conjugate (ADC) for the treatment of cervical cancer in adults.
The company received the FDA’s approval after its Phase II clinical trial delivered promising results in terms of tumor response and durability of the response, per the news outlet.
In the trial, conducted by Seagen and Genmab, Tivdak was studied in more than 100 patients who had recurrent or metastatic cervical cancer. The drug was found to have an objective response rate (ORR) of 95%, while the median duration of response (DOR) was 8.3 months.
In the United States, nearly 14,480 new cases of invasive cervical cancer are expected to be diagnosed in 2021, while around 4,290 women are likely to die from the disease.
Cervical cancer is a type of cancer that occurs in the cells of the cervix – the lower part of the uterus that connects to the vagina, according to Mayo Clinic. Various strains of the human papillomavirus (HPV), a sexually transmitted infection, play a role in causing most cervical cancer.
Lead investigator of the trial Dr. Robert Coleman of U.S. Oncology Research said, “Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients. This is an important development for patients with recurrent or metastatic cervical cancer.”
Dr. Coleman is the Chief Scientific Officer at the U.S. Oncology Research.
It is important to note that Tivdak is not without risk, as it comes with a warning of ocular toxicity, peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. However, the drug’s clinical benefits appear to outweigh the risks.
Genmab CEO Dr. Jan van de Winkel said, “Tivdak’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they are in need of a new treatment option and we look forward to making it available to them.”
“Today’s announcement marks Genmab’s evolution into a fully integrated biotechnology company and we would like to thank patients, caregivers, investigators, and our collaborators for their participation in our clinical studies,” he added. The story was published on BioSpace.
