FDA approves AVEO’s kidney cancer treatment
pharmafile | March 11, 2021 | News story | | Aveo, FDA, Kidney cancer, fotivda, rcc
The FDA has approved AVEO Oncology’s FOTIVDA drug for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC), a type of kidney cancer.
The oral therapy is the first approved in the US for adult patients with RCC who have previously received two or more systemic therapies.
AVEO’s first application to market the cancer treatment was rejected by the FDA in 2013, after a federal panel of outside experts voted to recommend against approval, despite seven years of prior development.
The company’s new application has been green-lighted following its Phase III TIVO-3 study, which compared FOTIVDA to sorafenib in relapsed or refractory RCC. The trial, which included 350 patients, measured a median progression-free survival of 5.6 months with FOTIVDA, compared to 3.9 with sorafenib.
AVEO plans to make FOTIVDA available to patients in the US by the end of this month.
Dr Brian Rini, Chief of Clinical Trials at Vanderbilt Ingram Cancer Center and Principal Investigator of the TIVO-3 trial, said: “Today’s approval of FOTIVDA provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to two or more prior systemic therapies.
“With advances in RCC treatment, patients are living longer, increasing the need for proven, well tolerated treatment options in the relapsed or refractory setting. The TIVO-3 study is the first positive Phase III study in RCC patients who received two or more prior systemic therapies, and also the first Phase III RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment.”
Michael Bailey, President and CEO of AVEO, added: “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.”
It is estimated that there are more than 400,000 new cases of RCC each year, with 175,000 deaths allowing to kidney cancer in 2018 worldwide.
Jack Goddard
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