The FDA approved Tivdak for certain patients with metastatic cervical cancer.
The Food and Drug Administration (FDA) approved Tivdak (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy, according to the agency.
The approval is based on findings from the innovaTV 301 trial, which included 502 patients with recurrent or metastatic cervical cancer who previously received at least two other systemic treatments — including chemotherapy with or without Avastin (bevacizumab) or an anti-PD1/PD-L1 agent.
READ MORE: Second-Line Tivdak ‘Very Beneficial’ in Cervical Cancer
Patients in the trial were randomly assigned to one of two groups. Half of the patients received intravenous Tivdak every three weeks, while the other half received the investigator’s choice of chemotherapy. The investigators chose from chemotherapy consisting of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. Patients all continued this therapy until disease progression or unacceptable side effects.
The main goal of the trial was to see if Tivdak led to better overall survival, which is the time patients live before death of any cause. Investigators on the study also noted progression-free survival (time from treatment until death or disease worsening) and confirmed objective response rate (percentage of patients whose disease shrinks or disappears).
The median overall survival was 11.5 months in the Tivdak group, compared with 9.5 months in the chemotherapy group. Tivdak also outperformed chemotherapy in progression-free survival, too, with medians of 4.2 months and 2.9 months, respectively. The confirmed objective response rate was 17.8% in the Tivdak group, and 5.2% in the chemotherapy group.
The most common side effects (including laboratory abnormalities) that occurred in 25% or more of patients were decreased hemoglobin, peripheral neuropathy (pain and tingling in the hands and feet), conjunctival adverse reactions, increased aspartate aminotransferase (which could indicate liver issues), fatigue, decreased sodium, nosebleed and constipation.
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