Aveo Oncology Wins FDA Approval for Kidney Cancer Drug

Aveo Oncology has announced FDA approval for Fotivda (tivozanib) for the treatment of adults with renal cell carcinoma (RCC) who meet certain treatment guidelines. Fotivda is a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) and was approved in August 2017 in the European Union and other EUSA countries.

According to the American Cancer Society, renal cell carcinoma is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents like Fotivda that target the VEGF pathway have shown significant antitumor activity in RCC.

“We believe in Fotivda’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory RCC, and today marks the culmination of many years of hard work and determination of many individuals to bring this therapy to patients,” said Michael Bailey, president and chief executive officer of AVEO. “With today’s approval, Aveo begins its journey as a commercial-stage company, a noteworthy accomplishment in our industry…”

Aveo has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck cancer, pancreatic cancer and acute myeloid leukemia and is conducting a randomized Phase 2 confirmatory clinical trial of ficlatuzumab for the potential treatment of head and neck cancer. Aveo’s pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb) in a Phase 1 clinical trial for the potential treatment of cancer cachexia and at least two additional earlier-stage monoclonal antibodies in oncology development. (Source: Aveo Website, 10 March, 2021)