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FDA cleared AVEO Oncology’s tivozanib (Fotivda) to treat adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies.
The drugmaker expects the oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor to be available by the end of March.
“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,” said Michael Bailey, president and CEO of AVEO, in a press release.
With advances in RCC treatment, patients are living longer, increasing the need for proven, well-tolerated treatment options in the relapsed or refractory setting,” said Brian Rini, MD, chief of clinical rials at the Vanderbilt Ingram Cancer Center and principal investigator of AVEO’s TIVO-3 trial.
AVEO’s TIVO-3 study is the first positive Phase 3 study in RCC patients who received 2 or more prior systemic therapies, and also the first Phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment, according to Rini.
“With this approval, I believe Fotivda represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape,” Rini said.
In the Phase 3 trial comparing Fotivda or sorafenib (Nexavar, other brands), median progression-free survival (PFS) was 5.6 months in the Fotivda arm versus 3.9 months in those treated with sorafenib. Median overall survival was 16.4 and 19.2 months for the Fotivda and sorafenib arms, respectively.
The objective response rate (ORR) was 18% for the Fotivda arm and 8% for the sorafenib arm.
According to an FDA press release, the most common adverse reactions were fatigue, hypertension, diarrhea, decrease appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.