FDA approves Tivdak for advanced cervical cancer
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The FDA granted accelerated approval to tisotumab vedotin-tftv for certain women with advanced cervical cancer.
The approval applies to use of the agent by women with recurrent or metastatic disease that progressed on or after chemotherapy.
Tisotumab vedotin-tftv (Tivdak; Genmab, Seagen) is an antibody-drug conjugate directed to tissue factor, a protein expressed on cervical cancer cells.
The FDA based approval on results of the phase 2 innovaTV 204 trial, which evaluated tisotumab vedotin-tftv for 101 women with recurrent or metastatic cervical cancer who had received up to two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen.
Confirmed objective response rate as assessed by independent review committee and duration of response served as the main efficacy outcomes.
Researchers reported a 24% (95% CI, 15.9-33.3) confirmed ORR. Median duration of response was 8.3 months (95% CI, 4.2-not reached).
The most common adverse events included decreased hemoglobin (52%), fatigue (50%), decreased lymphocytes (42%), nausea (41%), peripheral neuropathy (39%), alopecia (39%), epistaxis (39%), conjunctival adverse reactions (37%), hemorrhage (32%) and decreased leukocytes (30%).
The prescribing information for tisotumab vedotin-tftv includes a boxed warning for ocular toxicity, as well as warnings for peripheral neuropathy, hemorrhage, pneumonitis and embryo-fetal toxicity.
“Once recurrent or metastatic cervical cancer progresses, there is a need for more options for these patients,” Robert L. Coleman, MD, FACOG, FACS, chief scientific officer for U.S. Oncology Research and lead investigator of the innovaTV 204 clinical trial, said in a Genmab-issued press release. “This is an important development for patients with recurrent or metastatic cervical cancer.”
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