FDA grants priority review to tisotumab vedotin for advanced cervical cancer
The FDA granted priority review to tisotumab vedotin for treatment of certain women with cervical cancer, according to the agent’s manufacturer.
The designation applies to use of the agent by women with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy.
The biologics license application (BLA) seeks accelerated approval for this indication. The FDA is expected to make a decision by Oct. 10.
Tisotumab vedotin (Seagen and Genmab) is an investigational antibody-drug conjugate directed to tissue factor, a cell-surface protein expressed on multiple solid tumors. Tissue factor is associated with tumor growth, angiogenesis and metastasis.
“The FDA’s filing of the tisotumab vedotin BLA with priority review marks an important step forward for this antibody-drug conjugate as a potential treatment for patients with recurrent or metastatic cervical cancer,” Roger Dansey, MD, chief medical officer at Seagen, said in a company-issued press release. “We are collaborating closely with the FDA throughout the review process to make this important therapy available to patients.”
The BLA for tisotumab vedotin is based on results of the ongoing single-arm, phase 2 innovaTV 204 trial, designed to assess tisotumab vedotin monotherapy for 101 women with recurrent or metastatic cervical cancer who previously received doublet chemotherapy with or without bevacizumab (Avastin, Genentech). Women were eligible if they had received up to two prior lines of therapy in the recurrent or metastatic setting.
Confirmed objective response rate assessed by independent central review served as the primary endpoint. Secondary endpoints included duration of response, PFS, OS, safety and tolerability.
Researchers reported a confirmed ORR of 24% (95% CI, 15.9-33.3), with seven women (7%) achieving complete response and 17 women (17%) achieving partial response.
Results showed median OS of 12.1 months (95% CI, 9.6-13.9) and a 6-month OS rate of 79% (95% CI, 69.3-85.6).