Product Candidates

AVEO Pharmaceuticals is a biopharmaceutical company seeking to advance targeted medicines for oncology and other unmet medical needs. The Company’s lead candidate is tivozanib, an oral, once-daily, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective, long half-life inhibitor of all three VEGF receptors, which AVEO is seeking to develop and commercialize in North America as a treatment for renal cell carcinoma (RCC), hepatocellular carcinoma (HCC) and other cancers. On June 1, 2020, the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for tivozanib as a treatment for relapsed or refractory RCC and assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2021. Tivozanib (FOTIVDA®) is approved by the European Commission for the treatment of adult patients with advanced RCC in the European Union plus Norway, New Zealand and Iceland. AVEO is leveraging or seeks to leverage partnerships to develop and commercialize its pipeline of products and product candidates, including tivozanib in oncology and other indications in various geographies, and ficlatuzumab (HGF MAb) in head and neck cancer and pancreatic cancer. AVEO’s earlier-stage pipeline includes AV-203 (anti-ErbB3 MAb), AV-380 (GDF15 MAb) and AV-353 (Notch 3 MAb) drug candidates being developed for various oncology indications.

Tivozanib, ficlatuzumab, AV-203, AV-380 and AV-353 are investigational drugs and have not yet been approved by the U.S. Food and Drug Administration (FDA).