AVEO Oncology Submits NDA to FDA for Tivozanib in Renal Cell Carcinoma

The NDA submission is intended to support the approval of Tivozanib as a treatment for adult renal cell carcinoma in the United States.

White pills resting on a pink surface.

Massachusetts based biotechnology company AVEO Oncology (NASDAQ: AVEO) has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for tivozanib, an oral pharmacologic inhibitor of the vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a therapy for patients with renal cell carcinoma (RCC) that has relapsed or become refractory to other chemotherapeutic agents.

President and CEO of AVEO Oncology Michael Bailey stated, “NDA submission is a distinguishing milestone for any development stage biotechnology company, and our tivozanib NDA is an important step in our goal of providing an effective and more tolerable therapeutic option to patients with relapsed or refractory RCC.”

“The TIVO-3 study provides valuable insight into the potential sequencing of therapy following earlier TKI and immunotherapy treatment, an area of significant need for kidney cancer patients whose disease has relapsed or become refractory to multiple lines of therapy,” Dr. Bailey continued.

“All of us at AVEO offer our continued gratitude to the patients, caregivers, and investigators who participated in our clinical trials. We look forward to working closely with the FDA during their review process and remain hopeful that the study’s overall survival (OS) hazard ratio (HR) will continue to favor tivozanib at the time of the final readout, expected by June 2020,” Dr. Bailey continued.

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The submission of the NDA follows the completion of the phase 3 TIVO-3 clinical trial, which compared the utility of tivozanib to that of sorafenib for treating individuals with third- or fourth-line RCC. Three additional human studies, including an active phase 3 trial and two phase 2 trials, are also being used to support the NDA.

The company is expected to report the results of “a final OS analysis of the TIVO-3 study” at the American Society of Clinical Oncology annual meeting, which will be held from May 29th to the 31st. The NDA submission could be withdrawn depending on the results of the analysis.

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Tivozanib (FOTIVDA®) exerts potent inhibitory effects on each of the three VEGF receptor proteins and “is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.”

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The medication is thought to have immuno-modulatory effects, having been demonstrated to reduce the expansion of anti-inflammatory regulatory T cells, an immune cell subset frequently exploited by solid tumors to suppress the anti-cancer immune response.

Tivozanib is currently approved for the treatment of advanced RCC in adults in the European Union, the United Kingdom, Norway, New Zealand and Iceland. The NDA is intended to support the development and marketing of Tivozanib as a cancer treatment in North America.

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