FDA Approves Tivdak for Metastatic/Recurrent Cervical Cancer

The FDA approved Tivdak (tisotumab vedotin-tftv) for previously treated recurrent or metastatic cervical cancer that progressed after chemotherapy treatment, according to Seagen and Genmab, the manufacturer of the drug.

Tivdak is the first-ever antibody drug conjugate – a type of targeted treatment –approved for this patient population. The FDA’s decision to OK the drug was based on findings from the innovaTV 204 clinical trial, which evaluated Tivdak in 101 patients with recurrent/metastatic cervical cancer who received no more than two prior therapies including at least one platinum-based chemotherapy regimen.

“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients,” said Dr. Robert L. Coleman, chief scientific officer of US Oncology Research and lead investigator of the innovaTV 204 clinical trial, in a statement. “This is an important development for patients with recurrent or metastatic cervical cancer.”

In the trial, there was a 24% confirmed objective response rate, with average duration of response being 8.3 months. Considering that globally over 300,000 women die of cervical cancer every year, this new development is welcomed by patients, researchers and advocates alike.

“We are thrilled to see this new treatment approved by the FDA. We are grateful to have another option for this devastating disease,” said Tamika Felder, the founder of Cervivor.

However, like other drugs, Tivdak does come with risks and side effects. Notably, it has a boxed warning for ocular toxicity (eye issues) as well as warnings for peripheral neuropathy, hemorrhage, pneumonitis and embryo-fetal toxicity.

Common side effects that occurred in 25% or more of patients were: decreased hemoglobin (52%), fatigue (50%), lymphocytes decreased (42%), nausea (41%), peripheral neuropathy (39%), hair loss (39%), nose bleed (39%), conjunctival side effects (37%), hemorrhage (32%), leukocytes decreased (30%), creatinine increased (29%), dry eye (29%), prothrombin international normalized ratio increased (26%), activated partial thromboplastin time prolonged (26%), diarrhea (25%) and rash (25%).

The drug was granted an accelerated approval, meaning that continued approval is contingent upon findings in confirmatory trials.

“We are pleased with the accelerated approval of TIVDAK, Seagen’s third FDA-approved antibody-drug conjugate and fourth approved medicine. Our mission at Seagen is to develop medicines that make a difference for people impacted by cancer,” said Dr. Roger Dansey, chief medical officer of Seagen.

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